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 LEFT FOSSA COMPONENT TYY-NNNLF manufactured by Tmj Solutions, Inc..
[188935275]
The surgeon plans on placing a revision fossa component at a later date. The production documentation was reviewed and no nonconformance was identified. The device remains implanted, and the investigation is ongoing. A follow-up mdr will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[188935276]
The patient's left fossa component has been reported as fractured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00014 |
| MDR Report Key | 9803110 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2015-11-01 |
| 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 LEFT FOSSA COMPONENT |
| Generic Name | LEFT FOSSA COMPONENT |
| Product Code | LZD |
| Date Received | 2020-03-06 |
| Model Number | TYY-NNNLF |
| Catalog Number | TYY-NNNLF |
| Lot Number | W33851 |
| Device Expiration Date | 2017-08-01 |
| 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. Other | 2020-03-06 |