BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS REDUX REDUCTION SCREW 7.5 X 35MM

    MDR report key: 3792054 · Received May 6, 2014

    Report

    Report Number
    0009617544-2014-00206
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNH
    PMA / PMN Number
    K102235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE TULIP OF A MANTIS REDUX REDUCTION SCREW 7.5 X 35MM WAS REPORTED TO HAVE SPLAYED WHILE TRYING TO INSERT A BLOCKER DURING A L4-S1 ARTHRODESIS. THE SURGEON WAS UNABLE TO GET THE BLOCKER TO ENGAGE THE THREADING OF THE SCREW HEAD AND THEN HAD TO REMOVE THE SCREW TO FIND THE ABOVEMENTIONED DAMAGE OF THE TULIP. THE REPORTED ISSUE CAUSED A 15 MINUTE SURGICAL DELAY, BUT DID NOT HAVE ANY ADVERSE CONSEQUENCES TO THE PATIENT. THE SCREW, WHICH WAS DISCARDED AT THE HOSPITAL, WAS EITHER LOT 13A313 OR LOT 128754. A REVIEW OF BOTH LOTS MANUFACTURING RECORDS DID NOT REVEAL ANY PRODUCTION ISSUES. IT IS UNKNOWN WHETHER THE DAMAGE TO THE TULIP OCCURRED WHILE INSERTING THE BLOCKER OR AT SOME POINT PRIOR TO THAT STEP IN THE SURGERY. IT IS POSSIBLE THAT THE DAMAGE OCCURRED DURING DISTRACTION OF THE CONSTRUCT, WHICH REQUIRED DIRECT, OUTWARD LOADING OF THE SCREW-HEADS. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. CONCLUSION: BECAUSE THE DEVICE HAS NOT BEEN RETURNED THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REDUCTION, WHEN TIGHTENING THE NUT AFTER DISTRACTION, THE NUT HAD NO GRIP ONTO THE TULIP OF THE SCREW AND THE NUT TURNED IN THE AIR. THE SURGEON HAS THEREFORE REMOVED THE NUT, REMOVED THE STEM AND CHANGED THE MANTIS SCREW. THE REMOVED SCREW WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REDUCTION, WHEN TIGHTENING THE NUT AFTER DISTRACTION, THE NUT HAD NO GRIP ONTO THE TULIP OF THE SCREW AND THE NUT TURNED IN THE AIR. THE SURGEON HAS THEREFORE REMOVED THE NUT, REMOVED THE STEM AND CHANGED THE MANTIS SCREW. THE REMOVED SCREW WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270465 MANTIS REDUX REDUCTION SCREW 7.5 X 35MM IMPLANT- THORACO/LUMBAR SCREW MNH STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1