FDA Adverse Event
Injury
Summary report: N
PRODISC-C IMPLANT LARGE
MDR report key: 2120426
·
Received June 3, 2011
Report
- Report Number
- 2530088-2011-00154
- Event Type
- Injury
- Date Received
- June 3, 2011
- Report Date
- May 26, 2011
- Manufacturer
- SYNTHES BRANDYWINE PLANT
- Product Code
- MJO
- PMA / PMN Number
- P070001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING THE INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.
Description of Event or Problem · 1
PT STATUS POST PDC IMPLANTATION APPROX (B)(6) 2008 RETURNED TO SURGEON. X-RAYS SHOWED THE DISC WAS IN GOOD ALIGNMENT AND DID NOT MIGRATE. SURGEON THOUGHT THE PT'S POSITIONING OF THE NECK 3 YEARS LATER WAS SLIGHTLY KYPHOTIC AND DECIDED TO REMOVE THE PDC ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRODISC-C IMPLANT LARGE | PRODISC-C IMPLANT | MJO | SYNTHES BRANDYWINE PLANT | NA | 6337501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |