FDA Adverse Event
Injury
Summary report: N
PICCOLO COMPOSITE PROXIMAL FEMUR NAIL
MDR report key: 7942854
·
Received October 8, 2018
Report
- Report Number
- 9615128-2018-00007
- Event Type
- Injury
- Date Received
- October 8, 2018
- Date of Event
- August 1, 2018
- Report Date
- October 8, 2018
- Manufacturer
- CARBOFIX ORTHOPEDICS LTD.
- Product Code
- HSB
- UDI-DI
- 7290109336435
- PMA / PMN Number
- K153536
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
THE CASE INVOLVED NON UNION, WITH IMPLANT FAILURE 8 MONTHS POST IMPLANTATION. EXAMINATION OF THE INVOLVED NAIL INDICATED IT HAD A FATIGUE FRACTURE. EXAMINATION OF PRODUCTION RECORDS OF THE INVOLVED DEVICE INDICATED THE IMPLANT WAS MANUFACTURED ACCORDING TO SPECIFICATION. CASES OF NONUNION AS WELL AS SUBSEQUENT IMPLANT FATIGUE FRACTURE ARE KNOWN AND DOCUMENTED IN THE LITERATURE [1]. [1] JOHNSON NA ET AL., RISK FACTORS FOR INTRAMEDULLARY NAIL BREAKAGE IN PROXIMAL FEMORAL FRACTURES: A 10-YEAR RETROSPECTIVE REVIEW. ANN R COLL SURG ENGL. 2017; 99(2): 145-150.
Description of Event or Problem · 1
EIGHT MONTHS AFTER IMPLANTATION OF A PROXIMAL FEMUR NAIL, THE NAIL BROKE; A NON UNION CASE. DATE OF EVENT: (B)(6) 2018 (ACCURATE DATE OF EVENT IS UNKNOWN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785350 | PICCOLO COMPOSITE PROXIMAL FEMUR NAIL | PF NAIL | HSB | CARBOFIX ORTHOPEDICS LTD. | PPF00793 | 7290109336435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |