MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-10 for PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT TYY-NNNLM manufactured by Tmj Solutions, Inc..
[188935328]
The patient was unable to maintain the surgeon's planned occlusion and the patient dislocated. The surgeon attempted to reduce the patient's dislocation, but the mandibular component continued to dislocate. The surgeon plans on placing a revision mandibular component to accommodate the patient's current occlusion. The device remains implanted at this time; however, a supplement to this mdr will be submitted for the revision surgery.
Patient Sequence No: 1, Text Type: N, H10
[188935329]
The patient's left mandibular component is dislocated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031049-2020-00006 |
| MDR Report Key | 9690010 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2019-08-16 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2020-02-10 |
| 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 | 2020-02-10 |
| Model Number | TYY-NNNLM |
| Catalog Number | TYY-NNNLM |
| Lot Number | W28210 |
| Device Expiration Date | 2016-05-01 |
| 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 | 2020-02-10 |