MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-18 for CUSTOM MADE DEVICE COENEN PM-TMJ & MODEL N/A TMJPM-1083 manufactured by Biomet Microfixation.
[188494240]
Zimmer biomet complaint (b)(4). The device has been returned for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: unknown screws, part# unk, lot# unk. The user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[188494241]
It was reported a custom temporomandibular joint prosthesis caused an oral perforation and infection approximately two years post-operatively. It was believed that the implant was too large. A revision was performed wherein the implant was modified by grinding the mandible component in an effort to improve the fit. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00113 |
| MDR Report Key | 9723283 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2020-02-18 |
| 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. JENNIFER DELANEY |
| 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 | CUSTOM MADE DEVICE COENEN PM-TMJ & MODEL |
| Generic Name | CUSTOM DEVICE |
| Product Code | LZD |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2019-11-05 |
| Model Number | N/A |
| Catalog Number | TMJPM-1083 |
| Lot Number | 627360A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-18 |