FDA Adverse Event
Malfunction
Summary report: N
NORIAN SRS BONE VOID FILLER ROTARY MIX 10CC-STERILE
MDR report key: 3003429
·
Received February 28, 2013
Report
- Report Number
- 2939274-2013-10005
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- May 12, 2011
- Report Date
- May 12, 2011
- Manufacturer
- NORIAN
- Product Code
- MQV
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEB 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS PROVIDED
Description of Event or Problem · 1
IT WAS REPORTED THAT EXPIRED NORIAN SKELETAL REPAIR SYSTEM BONE VOID FILLER WAS IMPLANTED INTO THE PT. IT WAS DISCOVERED AFTER THE PROCEDURE THAT IT WAS EXPIRED. THE PRODUCT EXPIRED ON APR 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86882 | NORIAN SRS BONE VOID FILLER ROTARY MIX 10CC-STERILE | MQV | NORIAN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |