FDA Adverse Event
Injury
Summary report: N
LINKSYMPHOKNEE
MDR report key: 24754674
·
Received April 1, 2026
Report
- Report Number
- 3004371426-2026-00028
- Event Type
- Injury
- Date Received
- April 1, 2026
- Date of Event
- March 18, 2026
- Report Date
- March 20, 2026
- Manufacturer
- WALDEMAR LINK GMBH & CO. KG
- Product Code
- HXX
- UDI-DI
- 04026575302925
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
NOTIFIED LATE ON (B)(6) 2026 THAT A SURGERY WAS GOING TO BE PERFORMED BUT AN INSTRUMENT IN THE CCK TRAY HAD DISCOLORATION ON IT THAT LOOKED LIKE BLOOD OR RUST. THE SURGERY WAS CANCELLED AND PERFORMED ON (B)(6) 2026 INSTEAD, WITH THE INSTRUMENT REMOVED OUT OF THE TRAY. [CUSTOMER].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815673 | LINKSYMPHOKNEE | SCREWDRIVER FOR CONE ADAPTER | HXX | WALDEMAR LINK GMBH & CO. KG | 151-131/00 | C232029 | 04026575302925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |