MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-19 for TEMPOROMANDIBULAR JOINT-PATIENT MATCHED IMPLANT N/A TMJPMI-1532 manufactured by Biomet Microfixation.
[57931287]
(b)(4). A review of the device history records show the lot released with no recorded anomaly or deviation. The user facility is foreign; therefore a facility medwatch report will not be available. The product was implanted into the patient and therefore will not be returned for an evaluation. 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
[57931288]
It was reported that a template and a fossa implant from a tempormandibular joint (tmj) patient matched implant (pmi) system were missing a hole. It is reported that the surgeon created the missing holes. It was reported that this event presented no delay to the procedure and no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[63283601]
The complaint is the suture hole is missing from the fossa template and implant. The complaint was confirmed through intraoperative pictures. The most likely underlying cause is the design vendor sending the incorrect revision of the cad (computer aided design) file to zimmer biomet for manufacture.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001032347-2016-00602 |
| MDR Report Key | 6041877 |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-22 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-12-08 |
| Device Manufacturer Date | 2016-08-29 |
| Date Added to Maude | 2016-10-19 |
| 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 | TEMPOROMANDIBULAR JOINT-PATIENT MATCHED IMPLANT |
| Generic Name | PATIENT MATCHED IMPLANT |
| Product Code | MPI |
| Date Received | 2016-10-19 |
| Model Number | N/A |
| Catalog Number | TMJPMI-1532 |
| Lot Number | 707830A |
| ID Number | SEE H10 NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-10-19 |