Complaints Form

Contact Information

Reporter Name:

Phone

Reporter Email:

Sales Team Name:

Sales Team Phone:

Inventory Shipment Address:

If Additional information is needed regarding this event, follow-up questions will be sent to the reporter. If questions should be directed to someone else, please provide below:

Contact Name:

Contact Phone:

Contact Email:

Hospital/Complaint Information

Hospital/Clinic Name:

Surgeon Name:

Surgeon Phone:

Surgeon Email:

Hospital/Clinic Address:

Not applicable as the worn and/or damaged product was identified by a field representative during the distribution process and NOT at a hospital, nor was associated with any procedure. There was NO patient involvement or subsequent impact or harm that resulted from the device failure

Product Information

Product Line:

Tray number(s):

Quantity

Catalog # or Part #

Lot #

UDI

Item Description

Will the Device be Returned for Evaluation?

Yes

No

UNK*

N/A

Add/Remove Product

If the product cannot be returned, please provide rationale

Discarded

Rationale by Hospital

OtherOther

RMA NEEDED?

For implanted devices, date implanted:

For devices, date removed:

List any additional Integrity Implants or Non-Integrity Implants device(s) that were used to complete the procedure:

Event Information

Notification Date:

Event/Surgery Date:

date of report or date Integrity Implants became aware of event

Describe alleged event in detail:

Include information on impact to the patient or user and/or malfunction, if known

Did the device fail to perform as expected?

Yes

No

UNK*

N/A

Clearly Describe:

Did the event occur during a surgery?

Yes

No

UNK*

N/A

Request these document types from facility and attach:
– Pre-Op/ Intra-Op/ Post-Op Images/ X-Rays
– Initial or Revision Operative Records and/or Sticker Sheet(s)
– Other Detailed Documents of Patient Involved Surgery/ Procedure

Maximum file size: 8.39MB

Explain when the event occurred:

e.g. prior to surgery, outside of operation room, with the distributor or site etc.

Type of procedure performed:

Number of Levels:

Was there a death or impact to the patient?

Yes

No

UNK*

N/A

Clearly Describe:

Death or

Impact to Patient

Was there a medical intervention?

Yes

No

UNK*

N/A

Clearly Describe:

e.g. revision surgery, additional treatment, prescribed medication, additional appointments to see medical professional, etc.

Did the event cause a delay to the procedure?

Yes

No

UNK*

N/A

Add Delay in Minutes:

Describe the Reason for Delay:

Was another of the same device available in the OR to complete the procedure?

Yes

No

UNK*

N/A

(e.g. another similar device available in the OR with the same intended use)

Were there any contributing conditions related to the event?

Yes

No

UNK*

N/A

Clearly Describe:

e.g. trauma, illness, previous surgery, related non-compliance, patient anatomy, infection, etc.

Was the surgical technique for the product utilized?

Yes

No

UNK*

N/A

Clearly Describe:

For an instrument/ implant fracture, did any pieces fall into the patient?

Yes

No

UNK*

N/A

Were all pieces retrieved?

Yes

No

UNK*

N/A

Clearly Describe:

Please describe how the procedure was completed

Patient Information

Anonymized patient identifier:

Age at Time of Event:

Height:

ft/in

in

Weight:

lb

kg

Ethnicity:

Hispanic/Latino

Not Hispanic/Latino

UNK*

Race:

No Additional Information

Any information from the previous sections on this form that were left blank and/or marked UNK* have been requested from the Hospital/ Surgeon and it was confirmed that there is NO ADDITIONAL INFORMATION that is reasonably available for this event. Including, but not limited to, patient/product information, x-rays, operative notes, sticker sheets, photos, etc.

When and by whom was it communicated to you that there is no additional information or documents available?

Date

Name & Title:

Email

Phone

*Please note: You will be contacted if information is not complete or marked “UNK” and the above sectionis not confirmed and filled in.