BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø1.3 SELF-TAP L8

    MDR report key: 3091637 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02298
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. SINCE THE LOT NUMBER IS UNKNOWN WE ARE NOT ABLE TO VERIFY THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS. NO PRODUCT FAULT COULD BE DETECTED. WE SUPPOSE THAT SIMPLY TOO MUCH APPLIED MECHANICAL FORCE, WELL BEYOND ITS CALCULATED DESIGN WAS APPLIED DURING INSERTION. THE REASONS FOR SHEARING OFF MAY BE DIFFERENT. THE BORE HOLE POSSIBLY WAS NOT DRILLED DEEP ENOUGH OR THE DRILL DIAMETER WAS CHOSEN TOO SMALL. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT REPORTEDLY IS IN HIS 50'S. ADDITIONAL PRO CODE: MQN. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING INSERTION THE SCREW BROKE JUST BELOW THE HEAD. THE PATIENT WAS IN HIS 50'S WITH GOOD BONE. THE SCREW HEAD AND THE SHAFT WERE REMOVED FROM THE PATIENT. THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194960 CORTSCR Ø1.3 SELF-TAP L8 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1