MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT TYY-NNNNRM manufactured by Tmj Solutions, Inc..
[188935334]
This patient reported she had a nickel allergy. The surgeon removed the patient's existing left and right mandibular devices and placed revision all titanium mandibular components. Multiple mdr reports were filed for this event, please see associated report: 2031049-2020-00016.
Patient Sequence No: 1, Text Type: N, H10
[188935335]
The patient's left and right mandibular components were revised due to material sensitivity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00017 |
| MDR Report Key | 9857502 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2020-03-19 |
| 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, |
| Manufacturer Country | US |
| Manufacturer Phone | 6503391 |
| Manufacturer G1 | TMJ SOLUTIONS, INC. |
| Manufacturer Street | 6059 KING DRIVE |
| Manufacturer City | VENTURA, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT |
| Generic Name | RIGHT MANDIBULAR COMPONENT |
| Product Code | LZD |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-02-27 |
| Model Number | TYY-NNNNRM |
| Catalog Number | TYY-NNNNRM |
| Lot Number | W41762 |
| Device Expiration Date | 2019-05-01 |
| 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, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |