FDA Adverse Event
Other
Summary report: N
RSP SHOULDER
MDR report key: 1981276
·
Received February 2, 2011
Report
- Report Number
- 1644408-2011-00051
- Event Type
- Other
- Date Received
- February 2, 2011
- Date of Event
- January 21, 2011
- Report Date
- January 21, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWS
- PMA / PMN Number
- K051075
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - DUE TO SUBLUXING SOFT TISSUE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP SHOULDER | GLENOID HEAD W/RETAINING SCREW | KWS | ENCORE MEDICAL, L.P. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | (B)(4), LOT NA| (B)(4), LOT NA |