BEUDAMED
    FDA Adverse Event Other Summary report: N

    LARGE BONE OSCILLATING BLADE, BRAZOL COATED

    MDR report key: 526441 · Received May 18, 2004

    Report

    Report Number
    1017294-2004-00019
    Event Type
    Other
    Date Received
    May 18, 2004
    Date of Event
    April 23, 2004
    Report Date
    April 26, 2004
    Manufacturer
    LINVATEC CORP.
    Product Code
    GET
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT TOTAL KNEE REPLACEMENT SURGERY, ONE OF THE TEETH OF THE SAW BLADE BROKE OFF. THIS WAS NOT NOTED DURING SURGERY, BUT WAS SEEN ON THE POST-OPERATIVE X-RAY. THE TOOTH OF THE SAW BLADE IS IN THE PT'S SOFT TISSUE IN THE POSTERIOR KNEE. IT IS NOT IN OR NEAR THE JOINT. THIS WAS THE FIRST TIME THE BLADE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE BONE OSCILLATING BLADE, BRAZOL COATED OSCILLATING BLADE, BRAZOL COATED GET LINVATEC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other