BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3902657 · Received June 30, 2014

    Report

    Report Number
    0009617544-2014-00282
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; RESULTS: THE SCREWS WERE DISCARDED AT THE HOSPITAL. THE X-RAYS USED TO MAKE THE DIAGNOSIS WERE REQUESTED, BUT THEY WERE NOT AVAILABLE FOR REVIEW. THE PATIENT ALLEGEDLY HAS PARKINSON'S DISEASE, WHICH MAY OR MAY NOT HAVE HAD AN IMPACT ON THE PATIENT'S BONE QUALITY AND RESULTING SUITABILITY FOR SPINAL IMPLANTS. INFORMATION ON THE PATIENT'S BONE QUALITY WAS REQUESTED, BUT NO INFORMATION WAS PROVIDED. THE CONDITION OF THE PRODUCT IS UNKNOWN AND THE CAUSE OF THE POST-OPERATIVE LOOSENING CANNOT BE DETERMINED. CONCLUSION: THE MANTIS CANNULATED POLYAXIAL SCREWS WERE REPORTED TO HAVE LOST BONE INTEGRATION RESULTING IN LOOSENING POST-OPERATIVELY. THE ISSUE WAS IDENTIFIED BY X-RAY AND THE SCREWS WERE REMOVED DURING A REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 MANTIS SURGERY (T12-L1, L2-3) WAS PERFORMED. AFTER THAT IT WAS FOUND THAT THE SCREWS ARE PULLING OUT BECAUSE OF PARKINSON'S DISEASE. ON (B)(6) 2014 REVISION SURGERY WAS PERFORMED AND ALL THE IMPLANTS WERE EXTRACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 MANTIS SURGERY (T12-L1, L2-3) WAS PERFORMED. AFTER THAT IT WAS FOUND THAT THE SCREWS ARE PULLING OUT BECAUSE OF PARKINSON'S DISEASE. ON (B)(6) 2014 REVISION SURGERY WAS PERFORMED AND ALL THE IMPLANTS WERE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381033 UNKNOWN_SPINE_PRODUCT UNK NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1