BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLIFT ENDPLATE

    MDR report key: 12089204 · Received June 29, 2021

    Report

    Report Number
    0009617544-2021-00123
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    May 1, 2019
    Report Date
    June 29, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MQP
    PMA / PMN Number
    K060506
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED TO BE A VLIFT ENDCAP, CATALOGUE NUMBER AND LOT NUMBER UNKNOWN. VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. A REVIEW OF COMPLAINT HISTORY FOR SIMILAR EVENTS FOR THIS LOT COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED NOR WAS A VALID LOT NUMBER PROVIDED. A REVIEW OF STRYKER¿S NC/CAPA DATABASES FOR RECORDS ASSOCIATED WITH THIS DEVICE COULD NOT BE PERFORMED BECAUSE THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED AND COULD NOT BE IDENTIFIED. FROM VLIFT IFU: PATIENTS INVOLVED IN AN OCCUPATION OR ACTIVITY THAT APPLIES EXCESSIVE LOADING UPON THE IMPLANT (E.G., SUBSTANTIAL WALKING, RUNNING, LIFTING, OR MUSCLE STRAIN) MAY BE AT INCREASED RISK FOR FAILURE OF THE FUSION AND/OR THE DEVICE. PATIENTS SHOULD BE INSTRUCTED IN DETAIL ABOUT THE LIMITATIONS OF THE IMPLANTS, INCLUDING, BUT NOT LIMITED TO, THE IMPACT OF EXCESSIVE LOADING THROUGH PATIENT WEIGHT OR ACTIVITY, AND BE TAUGHT TO GOVERN THEIR ACTIVITIES ACCORDINGLY. THE PROCEDURE WILL NOT RESTORE FUNCTION TO THE LEVEL EXPECTED WITH A NORMAL, HEALTHY SPINE, AND THE PATIENT SHOULD NOT HAVE UNREALISTIC FUNCTIONAL EXPECTATIONS. WITHOUT RETURN OF THE DEVICE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE ARTICLE 'OUTCOMES AND COST-MINIMIZATION ANALYSIS OF CEMENT SPACERS VERSUS EXPANDABLE CAGES FOR POSTERIOR-ONLY RECONSTRUCTION OF METASTATIC SPINE CORPECTOMIES' IN ANNALS OF TRANSLATIONAL MEDICINE, VOLUME 7 (NUMBER 10) 2019, WAS REVIEWED. FROM 2007 TO 2014, 65 VERTEBRAL CORPECTOMIES FOR METASTATIC SPINE DISEASE (MSD) REQUIRING ANTERIOR COLUMN RECONSTRUCTION WERE PERFORMED. BASELINE AGE, BMI, COMORBIDITIES, AND DISEASE SEVERITY AS MEASURED BY TOKUHASHI SCORES WERE EQUIVALENT BETWEEN TREATMENT GROUPS. 32 PATIENTS WERE MALE, 33 PATIENTS WERE FEMALE. ALL RESECTIONS WERE SINGLE-STAGE RESECTIONS/RECONSTRUCTIONS OF THE VERTEBRAL BODY THROUGH A POSTERIOR-ONLY APPROACH. 36 PATIENTS (17 MALE, 19 FEMALE) WERE IMPLANTED WITH "SIMPLEX PMMA CEMENT" AND 29 PATIENTS (15 MALE, 14 FEMALE) WERE IMPLANTED WITH VLIFT VERTEBRAL BODY REPLACEMENTS. THE COHORTS HAD NO SIGNIFICANT DIFFERENCES IN OPERATIVE COMPLICATIONS, BLOOD LOSS, POSTOPERATIVE SURVIVAL, NUMBER OF SUBSEQUENT REOPERATIONS, OR CHANGES IN RADIOGRAPHIC ALIGNMENT. THE MOST COMMON COMPLICATIONS IN BOTH GROUPS WERE WOUND INFECTIONS REQUIRING INCISIONAL DEBRIDEMENT. IN THE VLIFT COHORT, ONLY ONE PATIENT REQUIRED REVISION FOR A DEVICE-RELATED FAILURE. IN THE PMMA COHORT, NO PATIENTS REQUIRED REVISION SURGERY FOR CEMENT SPACER FAILURE OR EXTRUSION. ONE VLIFT PATIENT REQUIRED REVISION TO TREAT A FRACTURED ENDPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983606 UNKNOWN VLIFT ENDPLATE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention