BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATIENT SPECIFIC FOSSA EMINENCE LEFT PROSTHESIS

    MDR report key: 1032465 · Received April 17, 2008

    Report

    Report Number
    1721760-2008-00001
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 17, 2008
    Manufacturer
    TMJ IMPLANTS, INC.
    Product Code
    LZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOSSA-EMINENCE AND CONDYLAR PROSTHESES MANUFACTURED FOR THIS PT'S TOTAL JOINT REPLACEMENT WAS DESIGNED USING AN ANATOMICAL MODEL GROWN USING THE PT'S CT-SCAN DATA. WHEN THIS CT-SCAN WAS TAKEN, THE PT'S PREVIOUS FOSSA-EMINENCE PROSTHESIS WAS STILL IMPLANTED. THIS PREVIOUS PROSTHESES WAS REMOVED FROM THE SLA MODEL PRIOR TO THE DESIGN OF THE NEW PROSTHESIS BUT UPON SURGICAL IMPLANTATION, THE FIT WAS NOT CORRECT.

    Description of Event or Problem · 1

    THE PT HAD A PT-SPECIFIC LEFT PARTIAL JOINT FOR 7 YRS. SURGERY WAS PLANNED TO REVISE TO A TOTAL JOINT. WHEN THE NEW FOSSA-EMINENCE PROSTHESIS WAS PLACED, IT DID NOT FIT THE PT'S ANATOMY. A SECOND SURGERY IS REQUIRED TO PLACE THE NEW TOTAL JOINT PROSTHESES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT SPECIFIC FOSSA EMINENCE LEFT PROSTHESIS FOSSA-EMINENCE LEFT PROSTHESIS LZD TMJ IMPLANTS, INC. CFEL 12138

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other