FDA Adverse Event
Malfunction
Summary report: N
ALLY BONE SCREW
MDR report key: 16464025
·
Received March 1, 2023
Report
- Report Number
- 3009394448-2023-00001
- Event Type
- Malfunction
- Date Received
- March 1, 2023
- Date of Event
- February 8, 2023
- Report Date
- March 1, 2023
- Manufacturer
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Product Code
- HWC
- PMA / PMN Number
- K170698
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE INDEX PROCEDURE WAS A ONE-LEVEL PSEUDARTHROSIS CASE AT LEVEL C4-C5. DURING THE PROCEDURE ONE SCREW WAS DEPLOYED INTO BONE OUTSIDE OF THE CAGE, SINCE THE PHYSICIAN BELIEVED THIS WAS IN BONE, THIS SCREW WAS LEFT IN PLACE. A SECOND CAGE AND SCREW WAS PLACED ON THE CONTRALATERAL SIDE WITHOUT ISSUE. THE CASE WAS COMPLETED SUCCESSFULLY. PROCEDURE OUTCOME WAS AS EXPECTED. NO KNOWN COMPLICATIONS ARISING FROM THIS EVENT, AND THE PATIENT IS RECOVERING WELL POST OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1147846 | ALLY BONE SCREW | Screw, fixation, bone | HWC | PROVIDENCE MEDICAL TECHNOLOGY, INC. | PD-32-301 | PA182201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |