MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-02 for PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TYY-NNNNM manufactured by Tmj Solutions, Inc..
[185116618]
The patient received bilateral tmj implants in 2016. The patient's teeth shifted after surgery and the patient developed an open anterior bite. A ct scan was taken of the patient's anatomy, and demonstrated that the left and right fossa components were not placed in their intended design positions. On (b)(6) 2020, the surgeon removed the malpositioned devices; however, he was not able to place the revision components. A separate mdr (2031049-2020-00012) will be submitted for this event.
Patient Sequence No: 1, Text Type: N, H10
[185116619]
The surgeon planned on placing revision bilateral tmj implants due to malocclusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00011 |
| MDR Report Key | 9777554 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Model Number | TYY-NNNNM |
| Catalog Number | TYY-NNNNM |
| Lot Number | W37631 |
| Device Expiration Date | 2018-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2020-03-02 |