BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L90 SST

    MDR report key: 2874623 · Received December 15, 2012

    Report

    Report Number
    8030965-2012-01585
    Event Type
    Malfunction
    Date Received
    December 15, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DIMENSIONS WERE CHECKED AND WERE FOUND TO BE IN COMPLIANCE. INVESTIGATION HAS SHOWN THE POSITIONING GROOVE OF THE SCREW HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. THE GROOVE IS EXPANDED JUST ENOUGH THAT IT IS NOT POSSIBLE TO PASS THE PLATE OVER IT. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE, AFTER THE INSERTION OF THE LAG SCREW, SURGEON TRIED TO APPLY THE PLATE. THE PLATE WOULD NOT GO OVER THE LAG SCREW. SURGEON REMOVED THE SCREW AND CHECKED WITH THE EXISTING PLATE AND AN ADDITIONAL PLATE, WHERE THEY FOUND THE LAG SCREW WAS TOO BIG IN BOTH CASES. SURGEON SELECTED ANOTHER LAG SCREW AND COMPLETED THE PROCEDURE. REPORTABLY, THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS/DCS-SCR Ø12.5 L90 SST DHS/DCS-SCREW HWC SYNTHES GMBH 7772655

    Patients

    Seq Age Sex Outcome Treatment
    1 LAG SCREW, PLATE