BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI CLICK''X® PEDICLE SCR PREASSEMBLED 55MM THRD LENGTH

    MDR report key: 3052978 · Received April 11, 2013

    Report

    Report Number
    8030965-2013-10830
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 16, 2012
    Report Date
    January 16, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION LEVEL L5 - S1 PROCEDURE, AS THE SURGEON WAS PERFORMING THE SPONDY REDUCTION AT L5, THE SCREW HEAD CAME OFF THE SCREW. SURGEON REMOVED THE SCREW AND THE ADJACENT SCREW, SELECTED ANOTHER TWO SCREWS WITH A LAGER DIAMETER, AND COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156378 7.0MM TI CLICK''X® PEDICLE SCR PREASSEMBLED 55MM THRD LENGTH NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1