BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 12089197 · Received June 29, 2021

    Report

    Report Number
    0009617544-2021-00122
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    January 1, 2018
    Report Date
    October 29, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MQP
    PMA / PMN Number
    K060506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'TOTAL EN BLOC SPONDYLECTOMY FOR SOLITARY METASTATIC TUMORS OF THE FOURTH LUMBAR SPINE IN A POSTERIOR-ONLY APPROACH' IN THE WORLD NEUROSURGERY JOURNAL , VOLUME 120 ( E8-E16) 2018, WAS REVIEWED. VISUAL, DIMENSIONAL, MATERIAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE NO DEVICES WERE RETURNED.   DEVICE AND COMPLAINT HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS A VALID LOT CODE WAS NOT PROVIDED AND COULD NOT BE OBTAINED. LIMITED INFORMATION REGARDING THE EVENT WAS MADE AVAILABLE TO STRYKER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. A ROOT CAUSE CANNOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED THE INVESTIGATION WILL BE REOPENED AND UPDATED.

    Description of Event or Problem · 0

    THIS RECORD CAPTURES A REVIEW OF 'TOTAL EN BLOC SPONDYLECTOMY FOR SOLITARY METASTATIC TUMORS OF THE FOURTH LUMBAR SPINE IN A POSTERIOR-ONLY APPROACH' FROM THE JOURNAL OF WORLD NEUROSURGERY (WORLD NEUROSURG. (2018) 120:E8-E16.HTTPS://DOI.ORG/10.1016/J.WNEU.2018.06.251). NINE PATIENTS WITH SOLITARY METASTATIC TUMORS OF THE FOURTH LUMBAR SPINE WERE RETROSPECTIVELY REVIEWED WHO UNDERWENT TOTAL EN BLOC SPONDYLECTOMY (TES) FROM JUNE 2012 TO DECEMBER 2015 UTILIZING VLIFT CAGES. THE AUTHOR STATES THAT '...NO IMPLANT FAILURES OR RELATED CLINICAL SYMPTOMS WERE FOUND'. IT WAS REPORTED THAT TWO PATIENTS EXPERIENCED INTRA-OPERATIVE DURAL TEARS.

    Additional Manufacturer Narrative · 1

    STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS RECORD CAPTURES A REVIEW OF 'TOTAL EN BLOC SPONDYLECTOMY FOR SOLITARY METASTATIC TUMORS OF THE FOURTH LUMBAR SPINE IN A POSTERIOR-ONLY APPROACH' FROM THE JOURNAL OF WORLD NEUROSURGERY (WORLD NEUROSURG. (2018) 120:E8-E16.HTTPS://DOI.ORG/10.1016/J.WNEU.2018.06.251). NINE PATIENTS WITH SOLITARY METASTATIC TUMORS OF THE FOURTH LUMBAR SPINE WERE RETROSPECTIVELY REVIEWED WHO UNDERWENT TOTAL EN BLOC SPONDYLECTOMY (TES) FROM JUNE 2012 TO DECEMBER 2015 UTILIZING VLIFT CAGES. THE AUTHOR STATES THAT '...NO IMPLANT FAILURES OR RELATED CLINICAL SYMPTOMS WERE FOUND'. IT WAS REPORTED THAT TWO PATIENTS EXPERIENCED INTRA-OPERATIVE DURAL TEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983189 UNKNOWN_SPINE_PRODUCT SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Other