BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

    MDR report key: 3130932 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02398
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 15, 2011
    Report Date
    April 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWP
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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)(4). METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, RESULTS - VISUAL INSPECTION ¿ INSPECTION OF THE RETURNED IMPLANTS REVEALED THAT THE HEADS ARE LOOSE ONCE THEY ARE TRIED TO BE CLICKED ON. IT WAS POSSIBLE TO REPRODUCE THE COMPLAINED MALFUNCTION BUT THIS COULD ALSO BE IN RELATION WITH THE WEAR MARKS ON THE SCREW HEADS, PRESUMABLY CAUSED BY NUMEROUS TRIALS. MANUFACTURING RECORD REVIEW - A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION AND WE ARE NOT AWARE OF ANY SIMILAR OCCURRENCE REGARDING THESE PARTICULAR LOTS. BASED ON THESE FINDINGS, THE CAUSE OF THE FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. CONCLUSION: A PRODUCTION DEFECT COULD NOT BE DETERMINED AND THE COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. FINALLY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 3D CLICK-X HEADS ARE LOOSE. WHILE TRYING TO CLICK THEM ON THE BONE SCREWS DURING SURGERY, THEY WOULD NOT ASSEMBLE CORRECTLY. ONCE THE ROD AND LOCKING CAP WERE PLACED, THE 3D HEAD WOULD POP OUT OF PLACE. THE TIME OF INTERVENTION WAS PROLONGED FOR ABOUT 30 MINUTES. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231466 CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN KWP SYNTHES GMBH 3686680

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention