MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TYY-NNNNM manufactured by Tmj Solutions, Inc..
[182472674]
This patient was scheduled to receive bilateral tmj implants on (b)(6) 2020; however, the surgeon was unable to replicate his operative plan. The surgeon placed spacers bilaterally and staged the patient. A new ct scan was taken of the patient, and new joints will be designed and produced.
Patient Sequence No: 1, Text Type: N, H10
[182472675]
The surgeon was unable to place these bilateral tmj implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00013 |
| MDR Report Key | 9800925 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2020-01-01 |
| Date Added to Maude | 2020-03-06 |
| 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 | MS. LORENA LUNDEEN |
| Manufacturer Street | 6059 KING DRIVE |
| Manufacturer City | VENTURA, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6503391 |
| Manufacturer G1 | TMJ SOLUTIONS, INC. |
| Manufacturer Street | 6059 KING DRIVE |
| Manufacturer City | VENTURA, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS |
| Generic Name | TEMPOROMANDIBULAR JOINT IMPLANT |
| Product Code | LZD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-10 |
| Model Number | TYY-NNNNM |
| Catalog Number | TYY-NNNNM |
| Lot Number | W53103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TMJ SOLUTIONS, INC. |
| Manufacturer Address | 6059 KING DRIVE VENTURA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |