FDA Adverse Event
Injury
Summary report: N
SILASTIC(R) SHEETING IMPLANTED IN TMJ
MDR report key: 105952
·
Received July 15, 1997
Report
- Report Number
- 1816403-1997-00698
- Event Type
- Injury
- Date Received
- July 15, 1997
- Report Date
- June 16, 1997
- Manufacturer
- DOW CORNING CORP.
- Product Code
- JAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
ATTORNEY ALLEGES THAT AFTER THE PLAINTIFF RECEIVED TEMPOROMANDIBULAR JOINT SURGERY HER CONDITION DID NOT IMPROVE, IT ACTUALLY WORSENED SUBSTANTIALLY. ATTORNEY ALSO ALLEGES THAT THE PLAINTIFF DEVELOPED A SEVERE TEMPOROMANDIBULAR JOINT DYSFUNCTION, SEVERE MYOFACIAL PAIN SYNDROME, FIBROMYALGIA AND CHRONIC PAIN. THE PLAINTIFF WILL REQUIRE FURTHER SURGICAL PROCEDURES WHICH MAY INCLUDE, BUT NOT NECESSARILY RESTRICTED TO, BONE GRAFTING, TEMPOROMANDIBULAR JAW JOINTS REPLACEMENT AND NERVE SEVERING. PLAINTIFF HAS SUFFERED SEVERE AND PERMANENT INJURIES, CONTINUES TO SUFFER FROM EMOTIONAL NERVOUS UPSET OCCASIONED BY HER INJURIES AND DISABILITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILASTIC(R) SHEETING IMPLANTED IN TMJ Implant | TEMPOROMANDIBULAR JOINT IMPLANT | JAZ | DOW CORNING CORP. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |