FDA Adverse Event
Injury
Summary report: N
MOBI-C CERVICAL DISC PROSTHESIS
MDR report key: 5475823
·
Received March 3, 2016
Report
- Report Number
- 3004903783-2016-00007
- Event Type
- Injury
- Date Received
- March 3, 2016
- Date of Event
- February 2, 2016
- Report Date
- March 2, 2016
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- PMA / PMN Number
- P110002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER E2014039 - LDR SPINE USA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF LDR MEDICAL (MANUFACTURER). REVIEW OF THE INITIAL POST OP X-RAYS PROVIDED AND COMMENTS FROM THE SURGEON INDICATE THAT THE PATIENT HAD DEVELOPED PROGRESSIVE SPONDYLOLISTHESIS DUE TO HYPERMOBILE FACET JOINTS. SURGEON DECIDED TO REMOVE AND REPLACE WITH FUSION AT C3/C4. THE DEVICE WAS SENT TO AN EXTERNAL LABORATORY FOR ANALYSIS AND RESULTS ARE PENDING.
Description of Event or Problem · 0
REVISION SURGERY TO REMOVE CERVICAL DISC ARTHROPLASTY DEVICE AND REPLACE WITH FUSION TREATMENT DUE TO HYPERMOBILE FACET JOINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133021 | MOBI-C CERVICAL DISC PROSTHESIS | MOBI-C CERVICAL DISC | MJO | LDR MEDICAL | MB3356 | 5222673 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |