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 LEFT MANDIBULAR COMPONENT TYY-NNNNLM manufactured by Tmj Solutions, Inc..
[185116099]
Six months after receiving bilateral tmj implants, the patient dislocated on the left side. The surgeon repositioned the mandibular component so that the condylar head would articulate in its intended design position in the fossa bearing. No additional consequences were reported.
Patient Sequence No: 1, Text Type: N, H10
[185116100]
The patient's left tmj devices dislocated. The surgeon repositioned the mandibular component.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00009 |
| MDR Report Key | 9753198 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-06-01 |
| 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 LEFT MANDIBULAR COMPONENT |
| Generic Name | LEFT MANDIBULAR COMPONENT |
| Product Code | LZD |
| Date Received | 2020-02-26 |
| Model Number | TYY-NNNNLM |
| Catalog Number | TYY-NNNNLM |
| Lot Number | W50140 |
| 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; 2. Required No Informationntervention | 2020-02-26 |