FDA Adverse Event
Malfunction
Summary report: N
SOVEREIGN SPINAL SYSTEM
MDR report key: 3023087
·
Received March 27, 2013
Report
- Report Number
- 1030489-2013-00868
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- February 27, 2013
- Report Date
- March 1, 2013
- Manufacturer
- MSD DEGGENDORF MFG
- Product Code
- MAX
- PMA / PMN Number
- K091813
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CAGE CRACKED DURING IMPACTION IN AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL PROCEDURE. THE CAGE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126954 | SOVEREIGN SPINAL SYSTEM | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR | MAX | MSD DEGGENDORF MFG | NA | 204087596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |