FDA Adverse Event
Injury
Summary report: N
CABLE AND SLEEVE SET
MDR report key: 17535602
·
Received August 12, 2023
Report
- Report Number
- MW5142497
- Event Type
- Injury
- Date Received
- August 12, 2023
- Date of Event
- December 15, 2021
- Report Date
- February 14, 2022
- Manufacturer
- STRYKER INC.
- Product Code
- JDQ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT WAS REVISED AS 2 STAGE INFECTION WAS REPORTED ORIGINAL IMPLANT DATE UNKNOWN. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1215764 | CABLE AND SLEEVE SET | CERCLAGE, FIXATION | JDQ | STRYKER INC. | 6704-0-510 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |