BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM

    MDR report key: 9131811 · Received September 27, 2019

    Report

    Report Number
    0009617544-2019-00113
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 31, 2020
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    UDI-DI
    04546540560575
    PMA / PMN Number
    K142381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 07 OCTOBER 2019. DATE OF EVENT HAS BEEN CORRECTED AND EVENT DESCRIPTION AND EVALUATION CODES. PATIENT CODE GRID HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. AS THE LOT NUMBER WAS FOUND TO BE INVALID FOR THIS DEVICE, A DEVICE AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. ACCORDING TO THE IFU: THE SURGEON MUST DISCUSS ALL PHYSICAL AND PSYCHOLOGICAL LIMITATIONS INHERENT TO THE USE OF THESE DEVICES WITH THE PATIENT. THIS INCLUDES THE REHABILITATION REGIMEN, PHYSICAL THERAPY, AND WEARING AN APPROPRIATE ORTHOSIS AS PRESCRIBED BY THE PHYSICIAN. PARTICULAR DISCUSSION SHOULD BE DIRECTED TO THE ISSUES OF PREMATURE WEIGHT BEARING, ACTIVITY LEVELS, AND THE NECESSITY FOR PERIODIC MEDICAL FOLLOW-UP. 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. DELAYED UNION OR NONUNION: 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. THE DEGREE OR SUCCESS OF UNION, LOADS PRODUCED BY WEIGHT BEARING, AND ACTIVITY LEVELS WILL, AMONG OTHER CONDITIONS, DICTATE THE LONGEVITY OF THE IMPLANT. IF A NONUNION DEVELOPS OR IF THE IMPLANTS LOOSEN, BEND OR BREAK, THE DEVICE(S) SHOULD BE REVISED OR REMOVED IMMEDIATELY BEFORE SERIOUS INJURY OCCURS. IT WAS REPORTED THAT FOR THE PAST 6 MONTHS, THE PATIENT EXPERIENCED A FALL AND REPEATEDLY VIOLATED THE POST-OPERATIVE REGIME. ADDITIONALLY THE DEVICE WAS IMPLANTED FOR OVER A YEAR AND FUSION WAS NOT ACHIEVED. AS THE DEVICE WAS NOT RETURNED A DEFINITE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER BASED ON WHAT WAS REPORTED THE MOST LIKELY ROOT CAUSE IS FRACTURE DUE TO REPEATED STRENUOUS ACTIVITY AND TRAUMA BROUGHT UPON BY PATIENT VIOLATIONS OF POST-OPERATIVE ACTIVITY. ADDITIONALLY, REPEATED STRESSES AND STRAINS BROUGHT ON BY DELAYED UNION MAY HAVE ALSO CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT A ROD FRACTURED POST-OPERATIVELY AT L2 TO L3. THE PATIENT HAS CONSTRUCTS IN PLACE FROM THE LUMBAR SPINE TO THE CERVICAL SPINE. THE CONSTRUCT IMPLANTED IN THE LUMBAR SPINE HAS A, "LONG SEGMENT WITH NO POINT OF FIXATION WHICH LEADS TO A INCORRECT DISTRIBUTION OF FORCES." THE DEVICE IS BELIEVED TO BE A XIA ROD BUT, UNTIL REVISION SURGERY OCCURS, THE PHYSICIAN CANNOT CONFIRM WHETHER THE DEVICE IS OF STRYKER OR NON-STRYKER MANUFACTURE. THE PATIENT HAS REPORTEDLY ACHIEVED FUSION. REVISION SURGERY IS PLANNED BUT HAS NOT YET BEEN SCHEDULED. IT WAS ADDITIONALLY NOTED THAT FOR THE PAST SIX MONTHS THE PATIENT HAS EXPERIENCED "SEVERAL TRAUMAS" SUCH AS A, "FALL FROM THE HEIGHT." THE PATIENT ALSO, "REPEATEDLY VIOLATED THE REGIME, SAT DOWN WITHOUT A CORSET AND BENT TO PUT ON SOCKS, THEN AGAIN BEGAN TO NOTE PAIN IN THE LUMBAR SPINE."

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT A ROD FRACTURED POST-OPERATIVELY AT L2 TO L3. THE PATIENT HAS CONSTRUCTS IN PLACE FROM THE LUMBAR SPINE TO THE CERVICAL SPINE. THE CONSTRUCT IMPLANTED IN THE LUMBAR SPINE HAS A, "LONG SEGMENT WITH NO POINT OF FIXATION WHICH LEADS TO A INCORRECT DISTRIBUTION OF FORCES." THE DEVICE IS BELIEVED TO BE A XIA ROD BUT, UNTIL REVISION SURGERY OCCURS, THE PHYSICIAN CANNOT CONFIRM WHETHER THE DEVICE IS OF STRYKER OR NON-STRYKER MANUFACTURE. THE PATIENT HAS REPORTEDLY ACHIEVED FUSION. REVISION SURGERY IS PLANNED BUT HAS NOT YET BEEN SCHEDULED. IT WAS ADDITIONALLY NOTED THAT FOR THE PAST SIX MONTHS THE PATIENT HAS EXPERIENCED "SEVERAL TRAUMAS" SUCH AS A, "FALL FROM THE HEIGHT." THE PATIENT ALSO, "REPEATEDLY VIOLATED THE REGIME, SAT DOWN WITHOUT A CORSET AND BENT TO PUT ON SOCKS, THEN AGAIN BEGAN TO NOTE PAIN IN THE LUMBAR SPINE."

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A ROD FRACTURED POST-OPERATIVELY AT L2 TO L3. THE PATIENT HAS CONSTRUCTS IN PLACE FROM THE LUMBAR SPINE TO THE CERVICAL SPINE. THE CONSTRUCT IMPLANTED IN THE LUMBAR SPINE HAS A, "LONG SEGMENT WITH NO POINT OF FIXATION WHICH LEADS TO A INCORRECT DISTRIBUTION OF FORCES." THE DEVICE IS BELIEVED TO BE A XIA ROD BUT, UNTIL REVISION SURGERY OCCURS, THE PHYSICIAN CANNOT CONFIRM WHETHER THE DEVICE IS OF STRYKER OR NON-STRYKER MANUFACTURE. THE PATIENT HAS REPORTEDLY ACHIEVED FUSION AND NO ADVERSE CONSEQUENCE TO THE PATIENT HAS BEEN REPORTED. REVISION SURGERY IS PLANNED BUT HAS NOT YET BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926161 XIA 3 TITANIUM ROD DIAM 6MM CP TI L 480MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US 48232480 ZGB 04546540560575

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR