FDA Adverse Event
Injury
Summary report: N
MOBI-C CERVICAL DISC PROSTHESIS
MDR report key: 3913777
·
Received June 10, 2014
Report
- Report Number
- 3004788213-2014-00010
- Event Type
- Injury
- Date Received
- June 10, 2014
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- PMA / PMN Number
- P110009
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE XRAYS INDICATE SUPERIOR PLATE MIGRATED ANTERIOR ON BOTH DEVICES, LIKELY DUE TO REDUCED ANTERIOR ENDPLATE STRUCTURE. DEVICES WERE RETAINED FOR BIOLOGIC EVAL, RESULTS PENDING.
Description of Event or Problem · 1
REF IMP# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 337433 | MOBI-C CERVICAL DISC PROSTHESIS | MOBI-C CERVICAL DISC | MJO | LDR MEDICAL | MB3355 | 5220084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |