FDA Adverse Event
Malfunction
Summary report: N
OMNISPAN
MDR report key: 1733213
·
Received June 14, 2010
Report
- Report Number
- 1221934-2010-00216
- Event Type
- Malfunction
- Date Received
- June 14, 2010
- Report Date
- May 4, 2010
- Manufacturer
- DEPUY MITEK
- Product Code
- MBI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS ON A LIMITED LAUNCH; THE DEVELOPMENT AND QUALITY TEAMS ARE MONITORING THIS PRODUCT. THIS PARTICULAR INSTANCE WAS TECHNIQUE DRIVEN; THERE WERE NO PATIENT CONSEQUENCES OR HARM. THIS COMPLAINT ESTABLISHED TO CAPTURE AND TREND. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.
Description of Event or Problem · 1
IMPLANTS DEPLOYED UNDER MENISCUS; SILICONE TUBE CAME OFF DURING DEPLOYMENT. SILICONE TUBE REMOVED, SUTURE AND ONE BACKSTOP REMOVED, SECOND IMPLANT LEFT IMPLANTED. NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNISPAN | MENISCAL FASTENER | MBI | DEPUY MITEK | 228141 | 3400971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |