FDA Adverse Event
Injury
Summary report: N
SUPERION INDIRECT DECOMPRESSION SYSTEM
MDR report key: 11735389
·
Received April 27, 2021
Report
- Report Number
- 3006630150-2021-01800
- Event Type
- Injury
- Date Received
- April 27, 2021
- Date of Event
- March 15, 2021
- Report Date
- April 27, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NQO
- UDI-DI
- 00884662000550
- PMA / PMN Number
- P140004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9814, MODEL: 101-9814, SERIAL: N/A, LOT: 800256.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN X-RAY DISPLAYED THAT THE PATIENT'S UPPER CAM LOBES OF THE IMPLANTED SPACER MIGRATED 1-2 MILLIMETERS. THE SLIGHT DEVICE MIGRATION DID NOT LEAD TO AN ADVERSE EVENT. THE PATIENT IS RECEIVING PAIN RELIEF. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NO FURTHER ACTION WILL BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628590 | SUPERION INDIRECT DECOMPRESSION SYSTEM | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE | NQO | BOSTON SCIENTIFIC NEUROMODULATION | 101-9814 | 800315 | 00884662000550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |