FDA Adverse Event
Injury
Summary report: N
2520274-2013-03200
MDR report key: 3193263
·
Received June 27, 2013
Report
- Report Number
- 2520274-2013-03200
- Event Type
- Injury
- Date Received
- June 27, 2013
- Date of Event
- June 26, 2010
- Report Date
- May 16, 2011
- Manufacturer
- SYNTHES, USA
- Product Code
- KTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.
Description of Event or Problem · 1
DISTAL END OF THE NAIL (PERI-IMPLANT) FRACTURE. REOPERATION A MONTH LATER, EXCHANGE OF SHORT PFNA TO LONG NAIL DUE TO THE PERI-IMPLANT FRACTURE. THIS IS 1 OF 1 REPORT FOR AN UNKNOWN NAIL FOR EVENT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292575 | KTW | SYNTHES, USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Required Intervention |