FDA Adverse Event
Injury
Summary report: N
FRP 316 VARIABLE ANGLE LOCKING SCREW, D:3.5MM X L:16.0MM
MDR report key: 7570229
·
Received June 5, 2018
Report
- Report Number
- 3009996260-2018-00001
- Event Type
- Injury
- Date Received
- June 5, 2018
- Date of Event
- May 10, 2018
- Report Date
- June 5, 2018
- Manufacturer
- FLOWER ORTHOPEDICS
- Product Code
- HWC
- UDI-DI
- 00840118100823
- PMA / PMN Number
- K123562
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE ORIGINAL SURGERY FOR THE IMPLANTATION OCCURRED ON (B)(6) 2017. THE LOCKING SCREW WAS SHOWN AS FRACTURED WITHIN THE X-RAY. THE BONE WAS NOT FUSED. THE MALUNION IS AN INHERENT RISK OF SURGERY. THE REVISION SURGERY OCCURRED ON (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412673 | FRP 316 VARIABLE ANGLE LOCKING SCREW, D:3.5MM X L:16.0MM | LOCKING SCREW | HWC | FLOWER ORTHOPEDICS | 2013200542 | 00840118100823 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |