BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 3080995 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10492
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE POLYAXIAL SCREW ASSEMBLY WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION WITH THE BODY, COLLET AND BONE SCREW ASSEMBLED. THERE WAS NO OBVIOUS VISUAL DAMAGE TO THE POLYAXIAL BODY. THE BE... THE THREADS IN THE SCREW HEAD WERE NEARLY SHEARED OFF FROM ENGAGEMENT WITH A HOLDING SLEEVE. THE CONDITION APPEARS TO BE THE RESULT OF THE HOLDING SLEEVE BECOMING LOOSE DURING SCREW INSERTION WHICH CONTRIBUTED TO THE BREAKAGE. THE POLYAXIAL SCREW DESIGN IS ACCEPTABLE FOR ITS INTENDED USE. THIS COMPLAINT IS INVALID 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 INFORMATION: THE FOLLOWING WAS MISSING FROM THE PRODUCT DEVELOPMENT EVALUATION ON THE INITIAL MEDWATCH; THE POLYAXIAL SCREW THREADS WERE DAMAGED BY THE HOLDING SLEEVE THREAD BECOMING LOOSE DURING SCREW INSERTION THEN MANIPULATING THE HOLDING SLEEVE OFF-AXIS. THE POLYAXIAL SCREW DESIGN IS ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L5-S1 FUSION WITH THE MATRIX AND T-PAL, THE SURGEON WENT TO INSERT A 7MM X 50MM MATRIX PEDICLE SCREW AT S1 AND HALFWAY THROUGH INSERTION, THE MATRIX SCREWDRIVER DISENGAGED FROM THE PEDICLE BONE SCREW, AND BROUGHT WITH IT THE POLYAXIAL HEAD OF THE MATRIX SCREW. THE SURGEON REMOVED THE PEDICLE SCREW AND INSERTED A NEW 7MM X 50MM POLYAXIAL SCREW. THE SCREW WAS INSERTED WITHOUT ANY COMPLICATIONS AND NO HARM WAS INCURRED BY THE PATIENT. UPON INSPECTION, THE INNER THREAD OF THE PEDICLE BONE SCREW WAS STRIPPED AND THE TOP THREAD OF THE BONE SCREW HAD COME OFF. THIS REPORT IS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182670 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6553700

    Patients

    Seq Age Sex Outcome Treatment
    1