FDA Adverse Event Injury Summary report: N

UNKNOWN_KIE_PRODUCT

MDR report key: 3132251 · Received May 29, 2013

Report

Report Number
0009610622-2013-00292
Event Type
Injury
Date Received
May 29, 2013
Date of Event
May 3, 2013
Report Date
May 3, 2013
Manufacturer
STRYKER OSTEOSYNTHESIS-KIEL
Product Code
HSB
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. (B)(4): DEVICE WILL NOT BE RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED THAT: THE PATIENT IS SCHEDULED FOR REVISION OF NAIL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
234225 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention