BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH

    MDR report key: 2960258 · Received February 14, 2013

    Report

    Report Number
    2530088-2013-00151
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT CLASSIFICATION CODE PROVIDED. SUBSEQUENT PRODUCT CODES: MNH, MNI, KWQ, KWP. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE POLYAXIAL SCREW WAS RECEIVED WITH SEVERAL NICKS AND SCRATCHES ON THE OUTER SURFACE OF THE POLYAXIAL HEAD. THIS MAY HAVE OCCURRED FROM THE REMOVAL OF THE SCREW FROM THE PATIENT. THERE ARE SOME SCRATCHES AT THE TOP OF THE DRIVE RECESS, ALONG CHAMFER. THE COLLET IS ROTATED OUT OF POSITION AND STUCK. IT IS ROTATED OUT OF PROPER POSITION COVERING THE RIVETS WHICH ARE MEANT TO SECURE THE COLLET. THE COLLET BEING ROTATED OUT OF POSITION WOULD CLEARLY PREVENT PROPER ASSEMBLY OF THE ROD AND LOCKING CAP. A HEAD ALIGNMENT TOOL IS AVAILABLE IN THE SET TO POSITION THE HEADS SO THAT THE ROD SLOTS LINE UP AND A ROD CAN BE INTRODUCED INTO THE HEADS OF THE SCREWS. THE TOOL ALSO MAINTAINS ALIGNMENT OF THE COLLET RELATIVE TO THE BODY. THE DESIGN IS FOR THE SLOTS TO ALIGN AND A TOOL IS PROVIDED TO INSURE ALIGNMENT. THE POLYAXIAL SCREWS ARE ASSEMBLED WITH THE COLLET ALIGNED PROPERLY AND A HEAD ALIGNMENT TOOL IS PROVIDED IN THE SET. THE TECHNIQUE GUIDE RECOMMENDS CONFIRMING THE POSITION PRIOR TO INSERTING THE RODS AND AN INSTRUMENT IS PROVIDED TO MAINTAIN ALIGNMENT DURING USE. IT DOES NOT APPEAR THAT THE TOOL WAS USED OR USED PROPERLY WHEN MANIPULATING THE POLYAXIAL HEAD AND THE COLLET BECAME ROTATED AS A RESULT.

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING AN L2-ILIUM FUSION USING MATRIX POLYAXIAL SCREWS. THE ROD WOULD NOT SEAT COMPLETELY INTO THE HEAD OF THE LEFT S1 SCREW AFTER CONNECTING MOST OF THE CONSTRUCT. SURGEON REMOVED THE ROD AND FOUND THE COLLET ON THE INSIDE OF THE HEAD APPEARED TILTED AND WAS BLOCKING THE ROD FROM SEATING. SURGEON REMOVED THE SCREW AND REPLACED IT WITH ANOTHER POLYAXIAL SCREW THAT WAS 1MM LARGER IN DIAMETER. THE ROD WAS REATTACHED TO THE NEW SCREW AND THE SURGERY WAS COMPLETED WITH NO FURTHER PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65035 7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH POLYAXIAL SCREW NKB SYNTHES BRANDYWINE 6753213

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR