FDA Adverse Event
Injury
Summary report: N
R90 SPACER
MDR report key: 2993041
·
Received March 7, 2013
Report
- Report Number
- 1030489-2013-00700
- Event Type
- Injury
- Date Received
- March 7, 2013
- Report Date
- February 6, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- MQP
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL SURGERY USING A SPACER AND A COMPETITOR'S SPINAL FIXATION SYSTEM. IT WAS REPORTED THAT SOMETIME DURING POST-OP, THE PATIENT WAS PARALYZED AND INCAPABLE OF WALKING WITHOUT A WALKER. IT WAS REPORTED THAT SOME PARTS OF THE CONSTRUCT WERE DETACHED FROM THE CONSTRUCT, AND THAT CAUSED NERVE INJURIES. THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT IS ABLE TO WALK WITH A STICK AFTER THE REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98147 | R90 SPACER | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | MQP | MEDTRONIC SOFAMOR DANEK USA, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |