FDA Adverse Event
Injury
Summary report: N
SUPERION INDIRECT DECOMPRESSION SYSTEM
MDR report key: 11140665
·
Received January 8, 2021
Report
- Report Number
- 3006630150-2020-06631
- Event Type
- Injury
- Date Received
- January 8, 2021
- Date of Event
- December 11, 2020
- Report Date
- February 5, 2021
- Manufacturer
- VERTIFLEX INC.
- Product Code
- NQO
- PMA / PMN Number
- P140004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT. UPN: 101-9812; MODEL: 101-9812; SERIAL: N/A; BATCH: 800320.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEG PAIN AGAIN. THE PATIENT MET WITH HER PHYSICIAN AND X-RAYS WERE TAKEN. THE PHYSICIAN DISCOVERED THAT THE BONE HAD COLLAPSED AROUND THE SPACER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD TWO IMPLANTED SPACERS AND IT IS UNKNOWN IF BOTH SPACERS WERE INVOLVED IN THE BONE COLLAPSING INCIDENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LEG PAIN AGAIN. THE PATIENT MET WITH HER PHYSICIAN AND X-RAYS WERE TAKEN. THE PHYSICIAN DISCOVERED THAT THE BONE HAD COLLAPSED AROUND THE SPACER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35145 | SUPERION INDIRECT DECOMPRESSION SYSTEM | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE | NQO | VERTIFLEX INC. | 101-9812 | 700082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |