FDA Adverse Event
Malfunction
Summary report: N
COLS
MDR report key: 14315550
·
Received May 7, 2022
Report
- Report Number
- 3003898228-2022-00003
- Event Type
- Malfunction
- Date Received
- May 7, 2022
- Date of Event
- April 8, 2022
- Report Date
- June 14, 2022
- Manufacturer
- FH INDUSTRIE
- Product Code
- HWC
- UDI-DI
- 03661489661396
- PMA / PMN Number
- K113591
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE SCREW SPLIT DURING IMPLANTATION IN THE PATIENT WITH THE SCREWDRIVER. THE SCREW WAS REMOVED, FAILED AND REPLACED WITH ANOTHER ONE.
Description of Event or Problem · 0
THE SCREW SPLIT DURING IMPLANTATION IN THE PATIENT WITH THE SCREWDRIVER. THE SCREW WAS REMOVED, FAILED AND REPLACED WITH ANOTHER ONE.
Description of Event or Problem · 0
THE SCREW SPLIT DURING IMPLANTATION IN THE PATIENT WITH THE SCREWDRIVER. THE SCREW WAS REMOVED, FAILED AND REPLACED WITH ANOTHER ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1204873 | COLS | COLS PEEK SCREW D10 L20 | HWC | FH INDUSTRIE | 266139 | M00554 | 03661489661396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |