BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX PEDICSCR Ø6.2 SELF-TAP MONOAX L50

    MDR report key: 3191208 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03251
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    November 21, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE DEVICE WAS IN SINGLE PARTS WHEN RECEIVED. IT SHOWS MARKS AND THE HOLDING-CLIP IS DEFORMED WHICH POINTS TO THE FACT THAT THE HEAD CAME APART DURING FORCIBLE OR INADEQUATE USE. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW CAME APART FROM THE CLICKX BODY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291135 CLICKX PEDICSCR Ø6.2 SELF-TAP MONOAX L50 HWC SYNTHES GMBH 2696551

    Patients

    Seq Age Sex Outcome Treatment
    1