FDA Adverse Event
Injury
Summary report: N
PERI-LOC 3.5MM T20 LOCK SCREW 42MM S-T
MDR report key: 2210980
·
Received August 13, 2011
Report
- Report Number
- 1020279-2011-00321
- Event Type
- Injury
- Date Received
- August 13, 2011
- Date of Event
- June 16, 2011
- Report Date
- August 12, 2011
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- HWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED AS FIVE LOCKING SCREWS BACKED OUT OF THE PERI-LOC PROXIMAL HUMERUS PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERI-LOC 3.5MM T20 LOCK SCREW 42MM S-T | LOCKING SCREW | HWC | SMITH & NEPHEW, INC. | 73825042 | 10HM00087A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | PRODUCT #73825040 |