FDA Adverse Event
Malfunction
Summary report: N
DEGEN PIN
MDR report key: 7808834
·
Received August 23, 2018
Report
- Report Number
- 7808834
- Event Type
- Malfunction
- Date Received
- August 23, 2018
- Date of Event
- August 1, 2018
- Report Date
- August 9, 2018
- Manufacturer
- DEGEN MEDICAL, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 0
A PLATE HOLDING PIN BROKE WHILE IN WOUND.
Description of Event or Problem · 1
A PLATE HOLDING PIN BROKE WHILE IN WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 649389 | DEGEN PIN | PLATE, FIXATION, BONE | HRS | DEGEN MEDICAL, INC. | 181099LQ1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12410 DA |