BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM

    MDR report key: 10602740 · Received September 29, 2020

    Report

    Report Number
    0009617544-2020-00165
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 1, 2010
    Report Date
    December 18, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    07613327002188
    PMA / PMN Number
    K122845
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D3 WAS CORRECTED FROM 'STRYKER SPINE- FRANCE' TO 'STRYKER SPINE- US. VISUAL, DIMENSIONAL, FUNCTIONAL AND MATERIAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE PERFORMED AS A VALID LOT NUMBER WAS NOT PROVIDED AND COULD NOT BE OBTAINED. PER ES2 SURGICAL TECHNIQUE: 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, THE COMPONENTS CANNOT BE EXPECTED TO INDEFINITELY WITHSTAND THE ACTIVITY LEVEL AND LOADS OF NORMAL HEALTHY BONE. INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES WHICH ARE USED TO OBTAIN ALIGNMENT UNTIL NORMAL HEALING OCCURS. IN THE EVENT THAT HEALING IS DELAYED, DOES NOT OCCUR, OR FAILURE TO IMMOBILIZE THE DELAYED/NONUNION RESULTS, THE IMPLANT WILL BE SUBJECT TO EXCESSIVE AND REPEATED STRESSES WHICH CAN EVENTUALLY CAUSE LOOSENING, BENDING OR FATIGUE FRACTURE. SINCE THE DEVICE WAS IMPLANTED FOR 5 YEARS AND 4 MONTHS, MOST LIKELY CAUSE OF REPORTED EVENT IS FATIGUE LOAD OVERTIME. H3 OTHER TEXT : SURGEON RETAINED

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT AN ES2 INTEGRATED BLADE SCREW AT S1 FRACTURED AND THE CONTRALATERAL ES2 INTEGRATED BLADE SCREW AT S1 WAS LOOSE IN THE BONE. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE FRACTURED SCREW.

    Additional Manufacturer Narrative · 1

    STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A ES2 INTEGRATED BLADE SCREW AT S1 FRACTURED AND THE CONTRALATERAL ES2 INTEGRATED BLADE SCREW AT WAS LOOSE IN THE BONE. THE PATIENT HAS BEEN REVISED. THIS REPORT REPRESENTS THE FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067447 ES2 INTEGRATED BLADE SCREW SIZE L 6.5X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 482804645 UNKNOWN 07613327002188

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention