FDA Adverse Event
Malfunction
Summary report: N
ALLY BONE SCREW
MDR report key: 15279529
·
Received August 23, 2022
Report
- Report Number
- 3009394448-2022-00003
- Event Type
- Malfunction
- Date Received
- August 23, 2022
- Date of Event
- July 25, 2022
- Report Date
- August 22, 2022
- 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 FOUR-LEVEL POSTERIOR CERVICAL FUSION FROM C3-C7. SEVEN IMPLANTS WERE PLACED AS EXPECTED. ON ONE IMPLANT A SCREW WAS SUSPECTED TO HAVE BROKEN OFF AND LODGED INSIDE THE IMPLANT. A SECOND SCREW WAS PLACED WITH NO ISSUE. NO LOOSE HARDWARE WAS NOTED ON X-RAYS. CASE WAS COMPLETED SUCCESSFULLY. PROCEDURE OUTCOME WAS AS EXPECTED. NO KNOWN COMPLICATIONS ARISING FROM THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2831812 | ALLY BONE SCREW | METALLIC BONE FIXATION FASTENER | HWC | PROVIDENCE MEDICAL TECHNOLOGY, INC. | PD-32-301 | PA212201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male |