FDA Adverse Event
Injury
Summary report: N
LCP 4.5/5 BROAD 13HO L242 TI
MDR report key: 2211306
·
Received August 3, 2011
Report
- Report Number
- 8030965-2011-00524
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 6, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
A DEVICE REPORT FROM WALDENBURG INDICATES A CLINIC IN (B)(6) REPORTED: PATIENT IMPLANTED WITH LCP PLATE ON AN UNKNOWN DATE RETURNED TO SURGEON FOR THREE MONTH POST OP VISIT. AN X-RAY SHOWED A BROKEN PLATE WITH A NON-UNION. MEDICAL/SURGICAL INTERVENTION WAS NEEDED ON AN UNKNOWN DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCP 4.5/5 BROAD 13HO L242 TI | LCP 4.5/5 BROAD 13HO PLATE | HRS | SYNTHES GMBH | 2403885 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | SCREW |