FDA Adverse Event
Injury
Summary report: N
PRODISC-C IMPLANT LARGE
MDR report key: 1202813
·
Received October 16, 2008
Report
- Report Number
- 2530088-2008-00049
- Event Type
- Injury
- Date Received
- October 16, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 16, 2008
- Manufacturer
- SYNTHES BRANDYWINE
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IMPLANT REPOSITIONED IN 2008. INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED. REVIEW OF THE MANUFACTURING RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
PRODISC-C IMPLANTED IN PT WITH HERNIATED NUCLEUS PULPOSUS C6-C7 FOR A CERVICAL ARTHROPLASTY PROCEDURE. SURGEON DETERMINED REPOSITIONING NECESSARY SECONDARY TO IMPLANT BEING TOO FAR POSTERIOR. IMPLANT REPOSITIONED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODISC-C IMPLANT LARGE | PRODISC-C IMPLANTS | MJO | SYNTHES BRANDYWINE | NA | 5796067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |