FDA Adverse Event
Injury
Summary report: N
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
MDR report key: 7359561
·
Received March 21, 2018
Report
- Report Number
- 3025141-2018-00125
- 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
Additional Manufacturer Narrative · 1
ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2018-00126: CASE 2.
Description of Event or Problem · 1
PATIENT WITH FRACTURES OF BOTH THE RADIUS AND ULNA WAS TREATED WITH A PLATE ON THE ULNA AND A INTERMEDULLARY NAIL IN THE RADIUS. THERE WAS NONUNION OF THE RADIUS. THE NAIL WAS REMOVED, A PLATE WAS APPLIED (SUPPLEMENTED WITH AN AUTOLOGOUS ILIAC BONE GRAFT) AND UNION WAS ACHIEVED. REFERENCE: SHAFT FRACTURES OF BOTH FOREARM BONES: THE OUTCOMES OF SURGICAL TREATMENT WITH PLATING ONLY AND COMBINED PLATING AND INTRAMEDULLARY NAILING. SANG BUM KIM, YOUN MOO HEO, JIN WOONG YI, JUNG BUM LEE, AND BYOUNG GU LIM. CLINICS IN ORTHOPEDIC SURGERY 2015; 7:282-290.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202140 | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |