BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX PEDICSCR Ø6.2 PREASSMBL L50 TAN D

    MDR report key: 2954831 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-00411
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 15, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS OF THE COMPLAINED CLICK X PEDICSCREW WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. OUR INVESTIGATIONS HAVE SHOWN THAT THE COMPLAINED CLICK X PEDICLE SCREW HAS INDEED SLIPPED OFF. WE DO SUPPOSE THOUGH THAT FAR TOO STRONG MECHANICAL FORCES HAVE CAUSED THE STRIPPING OF THE CLICK X HEAD, VISIBLE ON THE HEX-HEAD. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING THE OPERATION THE HEAD OF THE SCREW WAS COMING OFF. THERE WASN'T ANY IMPACT ON THE PROCEDURE, THE OPERATION WAS FINISHED SUCCESSFULLY. THIS REPORT IS #3 OF 3 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59840 CLICKX PEDICSCR Ø6.2 PREASSMBL L50 TAN D SCREW NKB SYNTHES GMBH 3448661

    Patients

    Seq Age Sex Outcome Treatment
    1