FDA Adverse Event
Summary report: N
1.5X5MM HT SD X-DR SCR, EA
MDR report key: 1935176
·
Received December 22, 2010
Report
- Report Number
- 1032347-2010-00203
- Date Received
- December 22, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 1, 2010
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HWC
- PMA / PMN Number
- K953385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE DOCTOR WAS IMPLANTING SCREWS, THREE OF THEM BROKE AND THE TIPS OF THE SCREWS REMAIN IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.5X5MM HT SD X-DR SCR, EA | BONE SCREW | HWC | BIOMET MICROFIXATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |