FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 14251931
·
Received April 29, 2022
Report
- Report Number
- 3005031160-2022-00018
- Event Type
- Injury
- Date Received
- April 29, 2022
- Report Date
- April 29, 2022
- Manufacturer
- XTANT MEDICAL HOLDINGS, INC.
- Product Code
- KWQ
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ON 3/30/2022 THE MANUFACTURER WAS MADE AWARE OF AN ALLEGED ADVERSE EVENT WHERE A SCREW USED IN AN ACDF PROCEDURE REPORTEDLY FAILED AND FRACTURED. RELEVANT INFORMATION RELATING TO THE IDENTIFICATION OF THE DEVICE WAS NOT PROVIDED, WHICH PRECLUDES IDENTIFICATION OF THE MANUFACTURER OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212857 | UNKNOWN | UNKNOWN | KWQ | XTANT MEDICAL HOLDINGS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |