BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 50

    MDR report key: 9586730 · Received January 14, 2020

    Report

    Report Number
    0009617544-2020-00008
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 18, 2019
    Report Date
    April 23, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    04546540450289
    PMA / PMN Number
    K121342
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: THE DEVICE WAS INSPECTED AND NO VISUAL ABNORMALITIES WERE FOUND ON THE SCREW SHAFT/THREADS. THERE WERE HEAVY, ASYMMETRICAL ROD INDENTATIONS FOUND ON THE HEAD OF THE SCREW. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND THERE WERE NO RELEVANT MANUFACTURING ISSUES IDENTIFIED AS ALL UNITS MET STRYKER SPECIFICATIONS. A REVIEW OF THE COMPLAINT HISTORY RECORDS WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS IDENTIFIED. PER SURGICAL TECHNIQUE: 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 DEVICES CANNOT AND DO NOT REPLICATE THE FLEXIBILITY, STRENGTH, RELIABILITY OR DURABILITY OF NORMAL HEALTHY BONE, THAT THE IMPLANTS CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY OR TRAUMA, AND THAT THE DEVICES 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 DEVICES. PATIENTS WHO SMOKE HAVE BEEN SHOWN TO HAVE AN INCREASED INCIDENCE OF NON-UNIONS. SURGEONS MUST ADVISE PATIENTS OF THIS FACT AND WARN OF THE POTENTIAL CONSEQUENCES. FOR DISEASED PATIENTS WITH DEGENERATIVE DISEASE, THE PROGRESSION OF DEGENERATIVE DISEASE MAY BE SO ADVANCED AT THE TIME OF IMPLANTATION THAT IT MAY SUBSTANTIALLY DECREASE THE EXPECTED USEFUL LIFE OF THE APPLIANCE. IN SUCH CASES, ORTHOPEDIC DEVICES MAY BE CONSIDERED ONLY AS A DELAYING TECHNIQUE OR TO PROVIDE TEMPORARY RELIEF. - LOOSENING OF SPINAL FIXATION IMPLANTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS, OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION, MIGRATION AND/OR PAIN. THE PATIENT HAD POOR BONE QUALITY WHICH IS MOST LIKELY CONTRIBUTED TO THE REPORTED SCREW MIGRATION. IT IS POSSIBLE THAT THE "HALOING" COULD HAVE BEEN CAUSED BY POOR BONE PURCHASE DUE TO POOR BONE QUALITY. HEAVY, ASYMMETRICAL ROD INDENTATIONS WERE ALSO FOUND ON THE SCREW HEADS OF THE TWO RETURNED SCREWS, FURTHER SUPPORTING THE IDEA THAT THE BLOCKER WAS OFF LOADED. AS THE RODS WERE NOT SEATED HORIZONTALLY INTO THE TULIP AND THE BLOCKERS WERE NOT TORQUED TO THE RECOMMENDED 8NM, IT IS LIKELY THAT THE UNEVEN FORCE DISTRIBUTION CREATED INSTABILITY IN THE CONSTRUCT. THIS COULD HAVE CAUSED THE ROD TO SLIP/MIGRATE FROM THE TULIP. IT IS ALSO POSSIBLE THAT THE INSTABILITY IN THE CONSTRUCT MAY HAVE ALSO CONTRIBUTED TO THE MIGRATION OF THE S1 SCREWS, ALONG WITH THE PATIENTS POOR BONE QUALITY.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT A XIA TITANIUM 4.5 POLYAXIAL SCREW DISENGAGED LESS THAN 1 MONTH POST-OPERATIVELY. REVISION SURGERY HAS OCCURRED.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A XIA TITANIUM 4.5 POLYAXIAL SCREW DISENGAGED LESS THAN 1 MONTH POST- OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50619 XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 50 THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 48146550 186122 04546540450289

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention