FDA Adverse Event
Injury
Summary report: N
SUPERION INDIRECT DECOMPRESSION SYSTEM
MDR report key: 11283180
·
Received February 4, 2021
Report
- Report Number
- 3006630150-2021-00292
- Event Type
- Injury
- Date Received
- February 4, 2021
- Date of Event
- January 12, 2021
- Report Date
- February 4, 2021
- Manufacturer
- VERTIFLEX INC.
- Product Code
- NQO
- UDI-DI
- 00884662000550
- PMA / PMN Number
- P140004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: (B)(4), MODEL: 101-9814, SERIAL: N/A, BATCH: 800256.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A FALL, THE PATIENT EXPERIENCED LOSS OF PAIN RELIEF. IT WAS ASSESSED THAT THE IMPLANT HAD MOVED SLIGHTLY SO THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE THE PLAN WAS TO REVISE THE IMPLANT. HOWEVER, DURING THE SURGERY, IT WAS DETERMINED THAT THE PATIENT HAD A SPINOUS PROCESS FRACTURE. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE IMPLANT BUT WAS UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177377 | SUPERION INDIRECT DECOMPRESSION SYSTEM | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE | NQO | VERTIFLEX INC. | 101-9814 | 800256 | 00884662000550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |