BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL CORTICAL SCREW 5.0 X 35

    MDR report key: 9526680 · Received December 27, 2019

    Report

    Report Number
    3004024955-2019-00054
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 4, 2019
    Report Date
    March 20, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    PMA / PMN Number
    K152632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN CORRECTED FOLLOWING RETURN OF THE DEVICE: D1, D2, D4, AND G1.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION CONFIRMED THAT THE BODY OF THE SCREW WAS FRACTURED. MATERIAL ANALYSIS WAS PERFORMED ON A SIMILAR IMPLANT WITH THE SAME FAILURE MODE (SCREW FRACTURE POST-OP PR 212260). THE POLYAXIAL SCREW WAS FOUND TO HAVE FRACTURED IN FATIGUE DUE TO AN APPLIED UNIDIRECTIONAL FORCE. THEELEMENTAL CONSTITUENTS WERE AS SPECIFIED ON THE PRINT. NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. DEVICE AND COMPLAINT HISTORY RECORDS WERE REVIEWED AND NO RELEVANT MANUFACTURING ISSUES OR SIMILAR COMPLAINTS WERE IDENTIFIED. PER THE INSTRUCTIONS FOR USE (IFU): ONCE IMPLANTED, THE IMPLANTS ARE SUBJECTED TO STRESSES AND STRAINS. THESE REPEATED STRESSES ON THE IMPLANTS SHOULD BE TAKEN INTO CONSIDERATION BY THE SURGEON AT THE TIME OF THE CHOICE OF THE IMPLANT, DURING IMPLANTATION AS WELL AS IN THE POST-OPERATIVE FOLLOW-UP PERIOD. INDEED, THE STRESSES AND STRAINS ON THE IMPLANTS MAY CAUSE METAL FATIGUE OR FRACTURE OR DEFORMATION OF THE IMPLANTS, BEFORE THE BONE GRAFT HAS BECOME COMPLETELY CONSOLIDATE. WHILE THE EXPECTED LIFE OF SPINAL IMPLANT COMPONENTS IS DIFFICULT TO ESTIMATE, IT IS FINITE. THESE COMPONENTS ARE MADE OF FOREIGN MATERIALS WHICH ARE PLACED WITHIN THE BODY FOR THE POTENTIAL FUSION OF THE SPINE AND REDUCTION OF PAIN. HOWEVER, DUE TO THE MANY BIOLOGICAL, MECHANICAL AND PHYSICOCHEMICAL FACTORS WHICH AFFECT THESE DEVICES BUT CANNOT BE EVALUATED IN VIVO. ADVERSE EFFECTS MAY NECESSITATE REOPERATION OR REVISION. THE SURGEON MUST WARN THE PATIENT OF THE SURGICAL RISKS AND MAKE AWARE OF POSSIBLE ADVERSE EFFECTS. THE SURGEON MUST WARN THE PATIENT THAT THE DEVICE CANNOT AND DOES NOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE, THAT THE IMPLANT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA, AND THAT THE DEVICE MAY NEED TO BE REPLACED IN THE FUTURE. IF THE PATIENT IS INVOLVED IN AN OCCUPATION OR ACTIVITY WHICH APPLIES INORDINATE STRESS UPON THE IMPLANT (E.G., SUBSTANTIAL WALKING, RUNNING, LIFTING, OR MUSCLE STRAIN) THE SURGEON MUST ADVISE THE PATIENT THAT RESULTANT FORCES CAN CAUSE FAILURE OF THE DEVICE. THE ROOT CAUSE OF REPORTED EVENT IS MOST LIKELY FRACTURE DUE TO FATIGUE (SCREW WAS IMPLANTED FOR APPROXIMATELY 3.5 YEARS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FRACTURED POST-OPERATIVELY. THE FRACTURED SCREW WAS DISCOVERED WHILE PERFORMING REVISION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCREW FRACTURED POST-OPERATIVELY. THE FRACTURED SCREW WAS DISCOVERED WHILE PERFORMING REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RECEIVED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW FRACTURED POST-OPERATIVELY. THE FRACTURED SCREW WAS DISCOVERED WHILE PERFORMING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322696 POLYAXIAL CORTICAL SCREW 5.0 X 35 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 15A726

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR