FDA Adverse Event
Injury
Summary report: N
SUPERION INDIRECT DECOMPRESSION SYSTEM
MDR report key: 11422700
·
Received March 5, 2021
Report
- Report Number
- 3006630150-2021-00734
- Event Type
- Injury
- Date Received
- March 5, 2021
- Date of Event
- January 28, 2021
- Report Date
- April 13, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- NQO
- PMA / PMN Number
- P140004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: 101-9810, LOT: 800184, DESCRIPTION: SUPERION IDS 10MM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS DEVICE MIGRATED AND AN EXPLANT HAS BEEN SCHEDULED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS DEVICE MIGRATED AND AN EXPLANT HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322257 | SUPERION INDIRECT DECOMPRESSION SYSTEM | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE | NQO | BOSTON SCIENTIFIC NEUROMODULATION | 101-9812 | 800138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |