FDA Adverse Event
Other
Summary report: N
SUBTALAR MBA IMPLANT 14MM
MDR report key: 2249625
·
Received August 19, 2011
Report
- Report Number
- 3004608878-2011-00120
- Event Type
- Other
- Date Received
- August 19, 2011
- Date of Event
- July 1, 2011
- Report Date
- August 19, 2011
- Manufacturer
- INTEGRA, CINCINNATI
- Product Code
- MJW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE USER FACILITY IMPLANTED TWO EXPIRED DEVICES ON (B)(6) 2011. THE PRODUCTS EXPIRED ON (B)(6) 2011. THE PATIENT WAS ANESTHETIZED AND IN THE OPERATING ROOM. HE NEEDED SIZE 14MM IMPLANTS. INTEGRA NO LONGER MARKET THIS SIZE IMPLANT. THE USER FACILITY ELECTED TO STERILE PROCESS THE DEVICES USING JOINT COMMISSION GUIDELINES. THE PRODUCTS WERE PURCHASED BY THE HOSPITAL ON 11/24/2006, THEREFORE, INVENTORY HAS BEEN IN THE POSSESSION OF THE HOSPITAL FOR ALMOST 5 YEARS. THE INTEGRA DISTRIBUTOR WAS NOT PRESENT AT THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUBTALAR MBA IMPLANT 14MM | NA | MJW | INTEGRA, CINCINNATI | 10138-14-10321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |