MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-10-26 for PATIENT MATCHED BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS N/A UNKNOWN manufactured by Biomet Microfixation.
[90296946]
The warnings in the package insert state this type of event can occur. The user facility is foreign; therefore a facility medwatch report will not be available. The product remains implanted and therefore will not be returned for an evaluation at this time. Because the part and lot numbers are unknown, the device history records could not be reviewed. It is stated the revision is due to heterotopic bone around the original implants and complex anatomy; therefore the event is related to patient condition. If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[90296947]
A revision surgery is planned for (b)(6) 2018 to remove and replace bilateral temporomandibular joint (tmj) implants due to heterotopic bone around the existing implants. More information was requested but has not been received at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2017-00771 |
| MDR Report Key | 6979129 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-26 |
| Date Mfgr Received | 2017-09-28 |
| Date Added to Maude | 2017-10-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| 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 | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT MATCHED BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS |
| Generic Name | CUSTOM JOINT IMPLANTS |
| Product Code | MPI |
| Date Received | 2017-10-26 |
| 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; 2. Required No Informationntervention | 2017-10-26 |