FDA Adverse Event Injury Summary report: N

TMJ FOSSA-EMINENCE & TMJ CONDYLAR PROSTHESIS SYSTEM

MDR report key: 224360 · Received May 20, 1999

Report

Report Number
1721760-1999-00019
Event Type
Injury
Date Received
May 20, 1999
Date of Event
March 16, 1999
Report Date
April 23, 1999
Manufacturer
TMJ IMPLANTS, INC.
Product Code
MPL
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

SURGEON STATES LOOSE SCREWS AND PAIN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TMJ FOSSA-EMINENCE & TMJ CONDYLAR PROSTHESIS SYSTEM Implant CONDYLAR SCREWS MPL TMJ IMPLANTS, INC. NA (2990) (5555) & (6035)

Patients

Seq Age Sex Outcome Treatment
1 36 YR Required Intervention