FDA Adverse Event
Injury
Summary report: N
2520274-2013-01598
MDR report key: 3011907
·
Received March 19, 2013
Report
- Report Number
- 2520274-2013-01598
- Event Type
- Injury
- Date Received
- March 19, 2013
- Report Date
- October 1, 2010
- Manufacturer
- SYNTHES (USA) WEST CHESTER, PA
- Product Code
- MCV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT AND NO FURTHER INVESTIGATION CAN BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED IN A N-HANCE - NFLEX PRESENTATION THAT ONE PATIENT WAS RE-OPERATED ON DUE TO SEVERE OSTEOPOROSIS, CAGE MIGRATION AND RELISTHESIS AT THE FUSION LEVEL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113687 | MCV | SYNTHES (USA) WEST CHESTER, PA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |