MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-02 for VITEK GLENOID FOSSA IMPLANT manufactured by Vitek, Inc..
[9672]
The pt underwent bilateral temporomandibular joint arthroplasty on 5/14/86 with the placement of 9 mm preformed glenoid fossa implants. After a stormy course of 1 1/2 yrs these implants were removed 2/16/88 and dermal grafts placed. She continued to do poorly and on 5/18/89, bilateral costochondral rib grafts were placed. There was residual foreign body granuloma at the surgery site 1989.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000564 |
| MDR Report Key | 11193 |
| Date Received | 1994-02-02 |
| Date of Report | 1994-01-12 |
| Date of Event | 1988-02-16 |
| Date Added to Maude | 1994-02-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK GLENOID FOSSA IMPLANT |
| Product Code | MDL |
| Date Received | 1994-02-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 11193 |
| Manufacturer | VITEK, INC. |
| Manufacturer Address | HOUSTON TX 77002 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Not Applicable; 2. Hospitalization; 3. Required No Informationntervention | 1994-02-02 |