FDA Adverse Event
Injury
Summary report: N
MOBI-C CERVICAL DISC PROSTHESIS
MDR report key: 4181813
·
Received August 29, 2014
Report
- Report Number
- 3004788213-2014-00015
- Event Type
- Injury
- Date Received
- August 29, 2014
- Date of Event
- January 31, 2014
- Report Date
- August 29, 2014
- Manufacturer
- LDR MEDICAL
- Product Code
- MJO
- PMA / PMN Number
- P110009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION CONCLUDED THAT EXCESSIVE ENDPLATE PREPARATION FOR IMPLANTING TDR DEVICE RESULTED IN COMPONENT MIGRATION.
Description of Event or Problem · 1
REVISION SURGERY TO REMOVE IMPLANTED TDR DEVICE DUE TO PATIENT ALLEGED PAIN. REFERENCE IMP #3004903783-2014-00015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 527794 | MOBI-C CERVICAL DISC PROSTHESIS | MOBI-C CERVICAL DISC | MJO | LDR MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |