MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-01-08 for OTOMIMIX N/A UNKNOWN manufactured by Biomet Microfixation.
[18531019]
The distributor reported, the implant broke two months after implantation and a revision surgery occurred.
Patient Sequence No: 1, Text Type: D, B5
[18753321]
The warnings in the package insert state this product should not be implanted on pediatric patients as the bones are still growing and forming. The user facility reported that the complaint item was discarded during the revision surgery and therefore not available for review by the manufacturer. The user facility reports that the revision was successful and the patient has been discharged from the hospital in stable condition. Without a known part or lot number, review of the manufacturing records cannot be performed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2013-00001 |
| MDR Report Key | 2901516 |
| Report Source | 01,07 |
| Date Received | 2013-01-08 |
| Date of Report | 2012-12-15 |
| Date Mfgr Received | 2012-12-15 |
| Date Added to Maude | 2013-01-08 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. AMANDA SISK |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OTOMIMIX |
| Generic Name | BONE CEMENT |
| Product Code | NEA |
| Date Received | 2013-01-08 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-01-08 |