FDA Adverse Event
Malfunction
Summary report: N
DJO SURGICAL
MDR report key: 20841385
·
Received December 4, 2024
Report
- Report Number
- 1644408-2024-01827
- Event Type
- Malfunction
- Date Received
- December 4, 2024
- Date of Event
- November 4, 2024
- Report Date
- December 3, 2024
- Manufacturer
- ENCORE MEDICAL L.P.
- Product Code
- KWS
- UDI-DI
- 00888912144391
- PMA / PMN Number
- K112069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2019-01273; 508-32-204 S801 - DEVICE CRACKED/BROKE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.
Description of Event or Problem · 0
REVISION SURGERY DUE TO THE BASEPLATE CENTER SCREW WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1839078 | DJO SURGICAL | RSP BASEPLATE, 30MM, W/P2 COATING | KWS | ENCORE MEDICAL L.P. | 769P2252 | 00888912144391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention | 506-03-118 LOT 832C1856| 506-03-122 LOT 833C1828| 506-03-130 LOT 835C1889| 508-32-103 LOT 864C4991| 509-02-032 LOT 951W1399 |