FDA Adverse Event
Malfunction
Summary report: N
SUPERION INTERSPINOUS SPACER
MDR report key: 12178386
·
Received July 15, 2021
Report
- Report Number
- 3006630150-2021-03805
- Event Type
- Malfunction
- Date Received
- July 15, 2021
- Date of Event
- September 1, 2020
- Report Date
- July 15, 2021
- Manufacturer
- VERTIFLEX INC.
- Product Code
- NQO
- PMA / PMN Number
- P140004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: APPROXIMATE DATE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT'S VERTIFLEX SPINAL IMPLANT IS NO LONGER IN THE CORRECT AREA. SHE ALSO STATED THAT THIS WAS CONFIRMED BY A HEALTH CARE PROVIDER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION, DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1074323 | SUPERION INTERSPINOUS SPACER | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE | NQO | VERTIFLEX INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |