FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-01611
MDR report key: 3013199
·
Received March 20, 2013
Report
- Report Number
- 2520274-2013-01611
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- April 8, 2008
- Manufacturer
- SYNTHES (USA) WEST CHESTER, PA
- Product Code
- MCV
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT. ACTUAL EVENT DATE NOT KNOWN. EXACT PART NUMBER COULD NOT BE IDENTIFIED. 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.
Additional Manufacturer Narrative · 1
NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED.(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE TWO NFIX II, N-HANCE PRODUCT COMPLAINTS. IT WAS FURTHER REPORTED THAT A PORTION OF THE DEVICES FROM ONE OF THE TWO SURGERIES HAS BEEN RETRIEVED, BUT HAD NOT YET BEEN RECEIVED BY SYNTHES FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THIS IS 1 OF 1 REPORT FOR COMPLAINT# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116076 | MCV | SYNTHES (USA) WEST CHESTER, PA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |