BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X16 MM

    MDR report key: 12586873 · Received October 6, 2021

    Report

    Report Number
    3004774118-2021-00302
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    June 1, 2021
    Report Date
    January 18, 2022
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    UDI-DI
    10888857392878
    PMA / PMN Number
    K172104
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT THE PATIENT BEGAN LIFTING WEIGHTS TOO SOON POST-OPERATIVELY, AND THE PATIENT EXPERIENCED A FALL 2-3 MONTHS POST-OP. PRE-OPERATIVE, INTRA-OPERATIVE, AND POST-OPERATIVE X-RAYS WERE REVIEWED AND THE FOLLOWING WAS OBSERVED. INTRA-OP X-RAY SHOWS THAT CAUDAL SCREW MAY BE SLIGHTLY PROUD AFTER SECURING MECHANISM IS LOCKED, INDICATING POTENTIAL OVER ANGULATION. THIS CAN BE OBSERVED MORE CLEARLY IN THE 2 WEEK POST-OP X-RAY. THE 2 WEEK POST-OP X-RAY SHOWS POSSIBLE CORTICAL DISRUPTION AT THE C7 INFERIOR ENDPLATE. THE 2 MONTH POST-OP X-RAY REVEALS A WEDGE FRACTURE OF C7 VERTEBRAE. THE FRACTURE RUNS FROM SUPERIOR/POSTERIOR CORNER OF C7 TO ANTERIOR EDGE OF C7. THERE IS SCREW MIGRATION NOTICED AT 2 MONTHS POST-OP. THE 4 MONTH POST-OP X-RAY SHOWS NO FUSION AT SUPERIOR ASPECT OF C6 AND AT BOTH ENDPLATES OF C6/7 DISC SPACE. SUPERIOR SCREW FRACTURE IS OBSERVED IN 6 MONTH POST-OP X-RAY. DEVICE AND COMPLAINT HISTORY RECORDS COULD NOT BE REVIEWED AS THE CORRESPONDING LOT NUMBER WAS NOT AVAILABLE. COMPLAINT HISTORY FOR THE CORRESPONDING CATALOG NUMBER WAS REVIEWED, AND NO ADVERSE TRENDS WERE OBSERVED. THE OZARK SURGICAL TECHNIQUE STATES: THE PATIENT MUST BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND THAT PHYSICAL ACTIVITY AND LOAD BEARING HAVE BEEN IMPLICATED IN PREMATURE LOOSENING, BENDING OR FRACTURE OF INTERNAL FIXATION DEVICES. THE PATIENT SHOULD UNDERSTAND THAT AN IMPLANT IS NOT AS STRONG AS A NORMAL, HEALTHY BONE AND WILL FRACTURE UNDER NORMAL LOAD BEARING IN THE ABSENCE OF COMPLETE BONE HEALING. AN ACTIVE, DEBILITATED OR UNCOOPERATIVE PATIENT WHO CANNOT PROPERLY RESTRICT ACTIVITIES MAY BE AT PARTICULAR RISK DURING POSTOPERATIVE REHABILITATION. ADEQUATELY INSTRUCT THE PATIENT. POSTOPERATIVE CARE AND THE PATIENT¿S ABILITY AND WILLINGNESS TO FOLLOW INSTRUCTIONS ARE TWO OF THE MOST IMPORTANT ASPECTS OF SUCCESSFUL HEALING. IT WAS CONFIRMED THAT THE PATIENT BEGAN LIFTING WEIGHTS TOO SOON AND SUSTAINED A FALL 2-3 MONTHS POST-OP. THE 2 MONTH POST-OP X-RAY REVEALS A VERTEBRAL BODY FRACTURE WHICH MOST LIKELY OCCURRED FROM EXCESSIVE ACTIVITY AND/OR PATIENT FALL. SUBSEQUENTLY, CRANIAL SCREWS FRACTURE AND PATIENT DID NOT ACHIEVE FUSION. A FRACTURED VERTEBRAE CAN COMPROMISE THE STRUCTURAL INTEGRITY OF THE ENTIRE CONSTRUCT. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE DUE TO PATIENT NON-COMPLIANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO OZARK SELF-TAPPING VARIABLE SCREWS FRACTURED SEVERAL MONTHS POST-OPERATIVELY DUE TO EXTERNAL TRAUMA (PATIENT FELL). UPON REVIEW OF PROVIDED IMAGING, IT WAS NOTED THAT THE SECURING MECHANISM OF THE OZARK PLATE FRACTURED AS WELL. THE FRACTURED DEVICES WERE LEFT IN PLACE, HOWEVER, REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO OZARK SELF-TAPPING VARIABLE SCREWS FRACTURED SEVERAL MONTHS POST-OPERATIVELY DUE TO EXTERNAL TRAUMA (PATIENT FELL). UPON REVIEW OF PROVIDED IMAGING, IT WAS NOTED THAT THE SECURING MECHANISM OF THE OZARK PLATE FRACTURED AS WELL. THE FRACTURED DEVICES WERE LEFT IN PLACE, HOWEVER, REVISION SURGERY WAS PERFORMED TO ADD POSTERIOR FIXATION. THIS RECORD CAPTURES THE SECOND OF THE TWO REPORTED OZARK SELF-TAPPING VARIABLE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481381 SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X16 MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ K2M, INC. 8801-04016CA UNKNOWN 10888857392878

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention