MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-15 for TMJ CONCEPTS manufactured by Tmj Concepts.
[1153921]
In 2008, got tmj concepts. Recently had an infection and had to have the devices removed approx four months later, and put back in seven months after that. Incision has not healed, bloody, drainage, weepy. Seizures started after second surgery. Head falls to the right side and cannot move. Other times, thrashes like a bull. Has had a 101-102 temp/staph infection since having the device. Infection started immediately after the implant went in. Pain got worse after the implant went in. Did not fix the 13 mm opening, now a 7 mm opening. Fossa was new, but the mandibular device was not new and was charged for a new device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012770 |
| MDR Report Key | 1477461 |
| Date Received | 2009-09-15 |
| Date of Report | 2009-09-15 |
| Date of Event | 2009-09-15 |
| Date Added to Maude | 2009-09-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMJ CONCEPTS |
| Generic Name | TMJ CONCEPTS |
| Product Code | JAZ |
| Date Received | 2009-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TMJ CONCEPTS |
| Manufacturer Address | VENTURA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2009-09-15 |