BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKX LOCKCAP F/498.571V TAV

    MDR report key: 3120726 · Received May 20, 2013

    Report

    Report Number
    8030965-2013-02287
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 25, 2011
    Report Date
    February 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. SUBMITTED IN ERROR, DUPLICATE COMPLAINT.

    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. ADDITIONAL NARRATIVE: THE MEASURABLE DIMENSION OF THE RETURNED LOCKING CAPS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND 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 THE SPECIFICATION AND WITHIN THE INTERNATIONAL STANDARD. THE RETURNED CAPS WERE SENT FOR INVESTIGATIONS. THE VISUAL INSPECTION REVEALED THE LOCKING CAPS SHOWED NO IRREGULAR MARKINGS. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE, AS NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE INVESTIGATION HAS DETERMINED THIS EVENT TO BE INDETERMINATE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    THE PATIENT HAD A 2 LEVEL POSTERIOR LUMBAR FUSION (PLF) WITH THE CLICK-X SYSTEM ON (B)(6) 2010. IMPLANTED WERE 6X SCREWS, 2X RODS, AND 6X LOCKING CAPS. IT WAS THEN NECESSARY FOR THIS PATIENT TO BE BOOKED FOR A REVISION PLF AFTER THE POST-OPERATIVE SCAN SHOWED THAT ALL 6 LOCKING CAPS HAD COME LOOSE AND BOTH RODS HAD SLIPPED. THE SURGEON REMOVED THE LOOSE LOCKING CAPS, REPOSITIONED THE RODS, THEN INSERTED 6 NEW LOCKING CAPS. THIS IS 4 OF 8 REPORTS FOR THIS INCIDENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221804 CLICKX LOCKCAP F/498.571V TAV HRS SYNTHES GMBH 3474687

    Patients

    Seq Age Sex Outcome Treatment
    1