BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 3041900 · Received April 8, 2013

    Report

    Report Number
    2530088-2013-10368
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE SCREW WAS RECEIVED WITH THE POLYAXIAL HEAD ASSEMBLED TO IT. THE HEAD WAS SEATED PROPERLY AND ROTATED FREELY AS INTENDED. THERE ARE MINOR SCUFFS AND DISCOLORATION ON THE BOTTOM SURFACE OF THE POLYAXIAL HEAD. THE STARDRIVE RECESS IN THE BONE SCREW IS SCRAPED AND THERE ARE NICKS EVIDENT ON THE EDGES OF THE POINTS. THE RETURNED PART IS ASSEMBLED PROPERLY AND FUNCTIONS AS INTENDED. THEREFORE THE COMPLAINT IS INVALID.

    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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE MATRIX POLYAXIAL SCREW HEAD DISENGAGED FROM THE BONE SCREW WHILE THE SURGEON WAS INSERTING THE SCREW INTO THE PEDICLE OF THE PATIENTS VERTEBRAE. THE SURGEON INSERTED A DIFFERENT MATRIX SCREW AND COMPLETED THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144018 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6849273

    Patients

    Seq Age Sex Outcome Treatment
    1