BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 980208 · Received October 19, 2007

    Report

    Report Number
    9611112-2007-00003
    Event Type
    Malfunction
    Date Received
    October 19, 2007
    Manufacturer
    HEBUMEDICAL GMBH
    Product Code
    LXT
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF HEBU'S PRODUCTION RECORDS REVEALED NO NON-CONFORMANCES IN SPECIFIED MATERIALS OR PRODUCTION PROCESSES DURING THE MANUFACTURE OF THIS LOT. THE DEVICES AGREED IN ALL RESPECTS WITH THE DESIGN SPECIFICATIONS (MASTER SAMPLE) RECEIVED FROM THE DISTRIBUTOR. THE HARDENING PROTOCOL CONFIRMED THAT THE MEASURED HARDNESS OF 44,9 HRC (MEDIAN VALUE) WAS WITHIN THE TOLERANCE RANGE SPECIFIED FOR SURGICAL STAINLESS STEEL. SINCE 2004, WHEN PRODUCTION OF THIS DEVICE COMMENCED, A LARGE QUANTITY OF INSTRUMENTS WAS SHIPPED TO THE DISTRIBUTOR BETWEEN 2004 TO JUNE, 2007 WHEN PRODUCTION OF THIS DESIGN CEASED. ALTHOUGH, WE WERE CONVINCED THAT THE TIP WOULD NOT BREAK UNLESS THE DEVICE WAS USED OTHER THAN INTENDED, A CAPA ACTION WAS INITIATED AFTER THE SECOND REPORTABLE INCIDENT: INSTEAD OF COMPLETELY SERRATING THE MOUTH PIECES, SERRATION WAS TERMINATED ABOUT ONE (1) CM BEFORE THE END OF EACH TIP. THIS CHANGE WAS DESIGNED TO STRENGTHEN THE DEVICE TIP WHEN USED FOR OTHER PURPOSES BUT WITHOUT REDUCING THE SAFETY AND EFFECTIVENESS OF THE DEVICE FOR ITS BONE HOLDING INDICATION. IN THE OPINION OF THE MFR, NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LXT HEBUMEDICAL GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1