BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS LONG CONSTRUCT HEX RAD ROD 6.0 X 50MM

    MDR report key: 2961668 · Received February 14, 2013

    Report

    Report Number
    0009617544-2013-00024
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    PMA / PMN Number
    K092631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, MICROGRAPHIC ANALYSIS, RISK ASSESSMENT. RESULT: AFTER VISUAL INSPECTION, THE BROKEN HEX TIP CONFIRMED THE REPORTED EVENT. THE LOT NUMBER OF THE MANTIS HEX ROD IS UNKNOWN. REVIEW OF COMPLAINT HISTORY: 2 PREVIOUS RECORDS HAVE BEEN RECEIVED REGARDING MANTIS ROD HEX TIP BREAKAGE. DURING INVESTIGATION OF PREVIOUS COMPLAINT, AN HEX TIP FRAGMENT WAS ANALYZED BY AN EXTERNAL LABORATORY BUT NO MICROGRAPHIC STRUCTURAL DEFECTS WERE OBSERVED. THE THREE REPORTS WERE FROM THE SAME SURGEON. THERE WAS NO ADVERSE CONSEQUENCE REPORTED TO THE PATIENT AS A RESULT OF THIS EVENT. CONCLUSION: THE BREAKAGE IS THE RESULT OF THE USER APPLYING EXCESSIVE CANTILEVER FORCE TO THE ROD WITH THE ROD INSERTER. DURING NORMAL USAGE, MANTIS HEX RODS CAN RESIST UP TO 16.9NM OF CANTILEVER FORCE WITH THE 90 DEGREE ROD INSERTER.

    Description of Event or Problem · 1

    AS REPORTED: "50MM MANTIS HEX RAD ROD #48486050 WAS PLACED ON 90DEGREE ROD INSERTER #48480091. ROD WAS INITIALLY PUT IN THROUGH THE S1 SCREW AND UP THROUGH L5 SCREW. THE MANTIS BLOCKER WAS PUT ON THE SCREW AT THE L5 LEVEL AND SLIGHTLY TIGHTENED. IN ORDER TO GET THE BLOCKER IN AT THE S1 SCREW, THE ROD INSERTER THAT WAS HOLDING THE ROD NEEDED TO BE FORCED DOWN IN ORDER TO ALLOW IT TO ACCEPT THE BLOCKER, AND DURING THE INSERTION OF THE BLOCKER, THE HEX PORTION OF THE ROD BROKE OFF INSIDE THE ROD INSERTER. SO HEX PIECE WAS REMOVED AND WILL BE SENT IN AFTER THIS PER IS FINISHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64782 MANTIS LONG CONSTRUCT HEX RAD ROD 6.0 X 50MM MANTIS LONG CONSTRUCT HEX RAD ROD 6.0 X 50MM NKB STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1