BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 26-36MM, 0°, 0-20°

    MDR report key: 14342122 · Received May 9, 2022

    Report

    Report Number
    3004774118-2022-00180
    Event Type
    Injury
    Date Received
    May 9, 2022
    Date of Event
    March 21, 2022
    Report Date
    August 19, 2022
    Manufacturer
    K2M, INC.
    Product Code
    MQP
    UDI-DI
    10888857370944
    PMA / PMN Number
    K180665
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE COULD NOT BE FUNCTIONALLY INSPECTED DUE TO THE EXISTING DAMAGE AND REMAINING TISSUE. THE DEVICE WAS INSPECTED VISUALLY. THE GOLD ANGLE LOCKING SCREW WAS SEVERELY STRIPPED ON THE BACK SIDE FROM OVER-TIGHTENING. THE TIN COATING WAS REMOVED FROM THE SURFACE ALONG WITH THE TOP LAYER OF MATERIAL, REVEALING UNCOATED METAL UNDERNEATH. THE METAL SCRAPED FROM THE SURFACE COLLECTED AT THE END OF THE STRIPPING DAMAGE. THE ROTATIONAL DIRECTION OF THE DAMAGE INDICATES STRIPPING OCCURRED DURING TIGHTENING. THROUGH THE WINDOWS IN THE CAGE HOUSING, THE RAISED GROOVES OF THREAD HEIGHT EXPANSION TOWER WERE OBSERVED TO BE SCRATCHED, DAMAGED, AND DEFORMED. THE ABRASIONS ON THE HEIGHT EXPANSION TOWER WERE CIRCUMFERENTIAL (FOLLOWING THE LENGTH OF THE GROOVES) WITH A SLIGHT NEGATIVE CURVATURE CONSISTENT WITH THE TOWER COLLAPSING. THE VISIBLE TOOTH OF THE HEIGHT RING EXHIBITED SOME DEFORMATION IN THE FORM OF DENTS ON ITS RIGHT SIDE. THE HEIGHT PIN (INSIDE THE CAGE ON TOP RIGHT THREADED HOLE) WAS SEVERELY DEFORMED WITH A CHUNK MISSING THAT APPEARS TO HAVE BROKEN OFF BY BRITTLE FRACTURE. DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS FOR THE REPORTED LOT NUMBER WERE IDENTIFIED. TO FINALIZE THE CONSTRUCT, THE ANGLE LOCKING SCREW AND PRE-STAKED HEIGHT LOCKING SCREW MUST BOTH BE FINAL TIGHTENED TO 12 IN-LBS (~1.4 N-M). THE OUS SURGICAL TECHNIQUE GUIDE STATES THAT THE ANGLE LOCKING SCREW IS TO BE FINAL TIGHTENED USING THE SIZE 10 NON-TAPERED DRIVER ATTACHED TO THE 12 IN-LBS TORQUE LIMITING HANDLE. THE TORQUE LIMITING HANDLE IS DESIGNED SUCH THAT THE SURGEON WILL HEAR A CLICK ONCE THE REQUIRED TORQUE IS ACHIEVED. APPLYING TORQUE BEYOND THE REQUIRED AMOUNT MAY DAMAGE THE SCREW AND WEAKEN THE CONSTRUCT. THE MOST LIKELY ROOT CAUSE IS OVER-TIGHTENING OF THE ANGLE LOCKING SCREW. THE ANGLE LOCKING SCREW WAS SEVERELY STRIPPED FROM EXCESSIVE TORQUE. THE LOSS OF MATERIAL LIKELY WEAKENED THE IMPLANT, ULTIMATELY LEADING TO ITS COLLAPSE WITHIN THE PATIENT.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT A CAPRI SMALL EXPANDABLE CORPECTOMY CAGE, "COLLAPSED A LITTLE INSIDE THE PATIENT." THE PATIENT HAS BEEN REVISED.

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE REPORTED THAT A CAPRI SMALL EXPANDABLE CORPECTOMY CAGE, "COLLAPSED A LITTLE INSIDE THE PATIENT." THE PATIENT HAS BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381012 CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 26-36MM, 0°, 0-20° SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP K2M, INC. 7512-21636L0-G3 MVBM-470830 10888857370944

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Required Intervention