FDA Adverse Event
Injury
Summary report: N
RECOPL 3.5 STRAIGHT 8HO L94 TI
MDR report key: 2211315
·
Received August 3, 2011
Report
- Report Number
- 8030965-2011-00527
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- June 10, 2011
- Report Date
- July 8, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT SVC. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.
Description of Event or Problem · 1
REC'D DEVICE REPORT FROM SYNTHES GMBH. PT IMPLANTED WITH A 3.5MM RECONSTRUCTION PLATE ON (B)(6) 2011 FOR A RADIAL DIAPHYSEAL REGION FRACTURE. PT COMPLAINED OF PAIN AND SURGEON FOUND PLATE TO BE BROKEN. REVISION PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECOPL 3.5 STRAIGHT 8HO L94 TI | RECOPL 3.5 STRAIGHT 8HO | HRS | SYNTHES GMBH | 2179094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | SCREW |