FDA Adverse Event
Injury
Summary report: N
ACUTRAK MINI
MDR report key: 8275854
·
Received January 24, 2019
Report
- Report Number
- 3025141-2019-00032
- Event Type
- Injury
- Date Received
- January 24, 2019
- Report Date
- January 11, 2019
- Manufacturer
- ACUMED LLC
- Product Code
- HWC
- PMA / PMN Number
- K930834
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MDR'S ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00033: CASE 2, 3025141-2019-00034: CASE 3, 3025141-2019-00035: CASE 4, 3025141-2019-00036: CASE 5.
Description of Event or Problem · 1
DURING IMPLANTATION OF AN ACUTRAK MINI SCREW IN THE HAND, A DISTAL PHALANX WAS FRACTURED. FRACTURE WAS MANAGED WITH THERMOPLASTIC SPLINTING AND UNION WAS OBSERVED AT 3 MONTHS POST OP. CASE 1. FROM: DISTAL INTERPHALANGEAL JOINT ARTHODESIS IN EXTENSION USING A HEADLESS COMPRESSIVE SCREW. KONAN, SUJITH; DAS, ADITI; TAYLOR, EMMA; SORENE, ELLIOT. ACTA ORTHOP. BELG., 2013, 79, 154-158.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69284 | ACUTRAK MINI | SCREW, FIXATION, BONE | HWC | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |