BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOSSA-EMINENCE PROSTHESIS: CONDYLAR PROSTHESIS

    MDR report key: 154669 · Received March 5, 1998

    Report

    Report Number
    1721760-1998-00001
    Event Type
    Injury
    Date Received
    March 5, 1998
    Date of Event
    January 26, 1998
    Manufacturer
    *
    Product Code
    LZD
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO 1) CORRECT BLOCK D6 TO BE CONSISTENT WITH TMJ IMPLANTS, INC. BASELINE REPORT AND 2) PROVIDE ADDITIONAL INFO RECEIVED FROM THE EXPLANTING PHYSICIAN. 1) THE TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM AND THE TMJ CONDYLAR PROSTHESIS SYSTEM REFERRED TO IN SECTION D-6 CONSISTS OF A FOSSA EMINENCE PROSTHESIS, FER-31-3056 AND A UNIVERSAL CONDYLAR PROSTHESIS, R/LCP-50-2074. 2) THE EXPLANTING PHYSICIAN HAD INDICATED THAT HE CANNOT DETERMINE WHETHER OR NOT THE PAIN SUFFERED BY THIS PT IS RELATED TO THE PROSTHESIS. THERE IS NO EVIDENCE SUBSTANTIATING DEVICE RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOSSA-EMINENCE PROSTHESIS: CONDYLAR PROSTHESIS TEMPOROMANDIBULAR JOINT PROSTHESIS LZD * TMJ FOSSA-EMINENCE (MORE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention