MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for PATIENT-FITTED TMJ LEFT FOSSA COMPONENT TYY-NNNNLF manufactured by Tmj Solutions, Inc..
[177815488]
This patient received bilateral tmj implants in (b)(6) 2019. Several months later, the patient developed a fistula that tracked to the left fossa component. The surgeon removed the fossa component. Tissue samples were taken for microbiology testing, and the results showed growth of (b)(6). The surgeon plans on placing a revision component once the infection has been resolved.
Patient Sequence No: 1, Text Type: N, H10
[177815489]
The patient's left fossa component was removed due to infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00005 |
| MDR Report Key | 9666728 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-04-01 |
| Date Added to Maude | 2020-02-04 |
| 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 930037398 |
| Manufacturer Country | US |
| Manufacturer Postal | 930037398 |
| Manufacturer Phone | 8056503391 |
| Manufacturer G1 | TMJ SOLUTIONS, INC. |
| Manufacturer Street | 6059 KING DRIVE |
| Manufacturer City | VENTURA CA 930037398 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 930037398 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT-FITTED TMJ LEFT FOSSA COMPONENT |
| Generic Name | LEFT FOSSA COMPONENT |
| Product Code | LZD |
| Date Received | 2020-02-04 |
| Model Number | TYY-NNNNLF |
| Catalog Number | TYY-NNNNLF |
| Lot Number | W49728 |
| 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 930037398 US 930037398 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |