MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-11 for SUBTALAR MBA IMPLANT 14MM 050114 manufactured by Integra, Cincinnati.
[2268606]
The reporter stated that the patient was anesthetized for a surgical procedure to implant the subtalar mba system (indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint). The surgeon requested a size 14 mm implant. The products available in the hospital inventory had an expiration date of june 30, 2011. The surgery was done on (b)(6) 2011. The user facility elected to reprocess the products in the hospital autoclave (with biological indicators) in accordance with joint commission protocols. There has been no adverse outcome for the patient to date. The products had been part of the hospital's own inventory.
Patient Sequence No: 1, Text Type: D, B5
[9257459]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2011-00113 |
| MDR Report Key | 2222539 |
| Report Source | 05,07 |
| Date Received | 2011-08-11 |
| Date of Report | 2011-08-11 |
| Date Mfgr Received | 2011-07-29 |
| Date Added to Maude | 2012-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBTALAR MBA IMPLANT 14MM |
| Generic Name | NA |
| Product Code | MJW |
| Date Received | 2011-08-11 |
| Catalog Number | 050114 |
| Lot Number | 7603-14-10321 |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, CINCINNATI |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-11 |