BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CLICKX LOCKING CAP FOR TI3-D HEAD

    MDR report key: 3083311 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11176
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    July 11, 2012
    Report Date
    July 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE HEXAGON RECESS OF ALL SIX LOCKING CAPS IS MORE OR LESS STRIPPED. THE RELEVANT DIMENSIONS OF THE HEXAGON RECESSES CAN NOT BE VERIFIED ANYMORE BECAUSE OF THE DAMAGE. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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 PRODUCT CODE: MNI. MANUFACTURING DATES: (B)(4)= 03/06/2008, (B)(4)= 10/26/2011, (B)(4)= 04/20/2012, (B)(4)= 05/09/2011, (B)(4)= 05/11/2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBAR FUSION, T10-L3 ALL SIX OF THE REPORTED LOCKING CAPS WERE STRIPPED. THE HEX IN THE TOP OF THE CAPS STRIPPED DURING THE FINAL TIGHTENING. THE SURGEON COMPLETED THE SURGERY, USING OTHER CAPS WITHOUT FURTHER INCIDENT. APPROXIMATELY 10-15 MINUTES WERE ADDED TO THE LENGTH OF THE SURGERY. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR SIX LOCKING CAPS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184084 TI CLICKX LOCKING CAP FOR TI3-D HEAD MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1