BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACROMIOPLASTY ELECTRODE

    MDR report key: 274152 · Received April 14, 2000

    Report

    Report Number
    1017294-2000-00053
    Event Type
    Other
    Date Received
    April 14, 2000
    Date of Event
    March 15, 2000
    Report Date
    March 16, 2000
    Manufacturer
    LINVATEC CORP
    Product Code
    JOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC SHOULDER SURGERY A SINGLE USE ACROMIOPLASTY ELECTRODE WAS USED. THE TIP OF THE DEVICE BROKE OFF DURING USE AND WAS NOT RECOVERABLE. A POST-OP X-RAY REVEALED THE RETAINED OBJECT. IT IS REPORTED THE PT WAS DISCHARGED AS EXPECTED. NO PT INJURY REPORTED AS OF THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROMIOPLASTY ELECTRODE ACROMIOPLASTY ELECTRODE JOS LINVATEC CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other