MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-26 for PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS TYY-NNNM manufactured by Tmj Solutions, Inc..
[185115525]
This patient received bilateral tmj implants in 2013. The patient developed intermittent right facial swelling that increased over the last four months and had a preauricular draining fistula with accompanying pain. The surgeon removed the right tmj devices and placed an antibiotic spacer. Tissue samples were taken for microbiology testing, and the results showed growth of parvimonas micra. The surgeon plans on placing revision components once the infection has been resolved.
Patient Sequence No: 1, Text Type: N, H10
[185115526]
The patient's right tmj devices were removed due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00010 |
| MDR Report Key | 9757955 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2020-02-26 |
| 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 | 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 | 2020-02-26 |
| Model Number | TYY-NNNM |
| Catalog Number | TYY-NNNM |
| Lot Number | W24932 |
| Device Expiration Date | 2015-01-01 |
| 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 | 2020-02-26 |