FDA Adverse Event
Malfunction
Summary report: N
DVR LOCK MINI L
MDR report key: 17527466
·
Received August 12, 2023
Report
- Report Number
- MW5134398
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- April 6, 2021
- Manufacturer
- LLC (DVR LOCK MINIL)
- Product Code
- LXT
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DURING SURGERY FOR DISTAL RADIUS ON (B)(6), 2021, A DVR CROSSLOCK PLATE WITH ARTICLE NUMBER: 1318-22-040 AND LOT NO: (01) 00880304533455 (10) J6842135 WOULD BE IMPLANTED. DURING THE OPERATION, 1.6 MM K-WIRE GOT CAUGHT IN THE PIN HOLE ITSELF AND COULD NOT BE REMOVED. A NEW DVR IMPLANT HAD TO REPLACE THE PREVIOUS ONE. THE INCIDENT MEANT NO INJURY TO THE PATIENT AND NO SIGNIFICANT INCREASE IN TIME FOR THE OPERATION. THE HOSPITAL HAS SAVED THE IMPLANT WITH K-WIRE THAT IS ATTACHED IF ZB NEEDS THE CONSTRUCTION FOR INSPECTION. DEPUY SYNTHES PRODUCT PART NUMBER: 292.160.10. (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 |
|---|---|---|---|---|---|---|---|
| 2204360 | DVR LOCK MINI L | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM | LXT | LLC (DVR LOCK MINIL) | (01) 00880304533455 (10) J6842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |