FDA Adverse Event
Injury
Summary report: N
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
MDR report key: 7359563
·
Received March 21, 2018
Report
- Report Number
- 3025141-2018-00127
- Event Type
- Injury
- Date Received
- March 21, 2018
- Report Date
- March 8, 2018
- Manufacturer
- ACUMED LLC
- Product Code
- HSB
- PMA / PMN Number
- K915613
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT WITH FRACTURES OF BOTH THE RADIUS AND ULNA WAS TREATED WITH INTERMEDULARY NAILS IN THE RADIUS AND ULNA. THERE WAS NONUNION OF THE ULNA. THE NAIL WAS REMOVED, A PLATE WAS APPLIED (SUPPLEMENTED WITH AN AUTOLOGOUS ILIAC CREST BONE GRAFT) AND UNION WAS ACHIEVED. REFERENCE: PLATE OSTEOSYNTHESIS VERSUS INTRAMEDULLARY NAILING FOR BOTH FOREARM BONES FRACTURES. SANG KI LEE, KAP JUNG KIM, JAE WON LEE, WON SIK CHOY. EUR J ORTHOP SURG TRAUMATOL (2014) 24:769-776.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202141 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |