FDA Adverse Event
Malfunction
Summary report: N
ACUTRAK SCREW
MDR report key: 8283686
·
Received January 28, 2019
Report
- Report Number
- 3025141-2019-00046
- Event Type
- Malfunction
- Date Received
- January 28, 2019
- Report Date
- January 16, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00047: CASE 2, 3025141-2019-00048: CASE 3, 3025141-2019-00049: CASE 4, 3025141-2019-00050: CASE 5, 3025141-2019-00051: CASE 6, 3025141-2019-00052: CASE 7, 3025141-2019-00053: CASE 8, 3025141-2019-00054: CASE 9, 3025141-2019-00055: CASE 10, 3025141-2019-00056: CASE 11.
Description of Event or Problem · 1
FOLLOWING IMPLANTATION OF AN ACUTRAK SCREW, THE PATIENT DEVELOPED POST TRAUMATIC ARTHROSIS. NO REVISION SURGERY WAS REQUIRED. CASE 1. FROM: ARTICLE: OPEN REDUCTION AND INTERNAL FIXATION OF CAPITELLAR FRACTURES WITH HEADLESS SCREWS. RUCHELSMAN, DAVID E.; TEJWANI, NIRMAL C.; KWON, YOUNG W.; EGOL, KENNETH A. J BONE JOINT SURG AM. 2008; 90: 1321-9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74793 | ACUTRAK SCREW | SCREW, FIXATION, BONE | HWC | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |