FDA Adverse Event
Malfunction
Summary report: N
SOVEREIGN SPINAL SYSTEM
MDR report key: 2160377
·
Received July 13, 2011
Report
- Report Number
- 1030489-2011-00884
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
- Product Code
- MAX
- PMA / PMN Number
- K091813
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE ALIF PROCEDURE AT L5-S1. THE CAGE WAS SUCCESSFULLY IMPACTED AND IT WAS PROCEEDED TO IMPLANT THE SCREWS. THE CAGE CRACKED THE CAGE WHILE TIGHTENING THE SCREW. NO COMPLICATIONS WERE OBSERVED OR NOTED AS A RESULT OF THE CAGE BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOVEREIGN SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH | NA | 204284383 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | SCREWS |