BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASYS BLOCKER

    MDR report key: 3900061 · Received June 27, 2014

    Report

    Report Number
    0009617544-2014-00279
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K032394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED; RESULTS: BLOCKER LOOSENING CAN BE CAUSED BY UNDER OR OVER TIGHTENING OF THE BLOCKER (RECOMMENDED TIGHTENING TORQUE IS 3 NM IN THE SURGICAL TECHNIQUE) HOWEVER THE EXACT CAUSE IS NOT DETERMINED/MULTIFACTORIAL. CONCLUSION: A OASYS BLOCKER WAS CONFIRMED VIA THE STRYKER REP AND X-RAYS TO HAVE LOOSENED. MANUFACTURING RECORDS WERE REVIEWED FOR THE PROVIDED LOT NUMBERS: CTW, BHJ AND NO ISSUES WERE FOUND. A REVISION SURGERY WAS NOT REQUIRED AT THE TIME OF REPORTING. NO BREACH IN OCCURRENCE AND/OR SEVERITY AND NO NEW HARMS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED; RESULTS: BLOCKER LOOSENING CAN BE CAUSED BY UNDER OR OVER TIGHTENING OF THE BLOCKER (RECOMMENDED TIGHTENING TORQUE IS 3 NM IN THE SURGICAL TECHNIQUE) HOWEVER THE EXACT CAUSE IS NOT DETERMINED/MULTIFACTORIAL. CONCLUSION: A OASYS BLOCKER WAS CONFIRMED VIA THE STRYKER REP AND X-RAYS TO HAVE LOOSENED. MANUFACTURING RECORDS COULD NOT BE REVIEWED BECAUSE NO LOT NUMBER WAS PROVIDED. A REVISION SURGERY WAS NOT REQUIRED AT THE TIME OF REPORTING. NO BREACH IN OCCURRENCE AND/OR SEVERITY AND NO NEW HARMS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT THE SURGERY WITH THE OASYS CERVICAL SYSTEM. THE SURGEON CONFIRMED X-RAY THAT THE BLOCKER (C2 RIGHT) LOOSENED. THEREFORE, THE SURGEON IS MONITORING FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT THE SURGERY WITH THE OASYS CERVICAL SYSTEM. THE SURGEON CONFIRMED X-RAY THAT THE BLOCKER (C2 RIGHT) LOOSENED. THEREFORE, THE SURGEON IS MONITORING FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT THE SURGERY WITH THE OASYS CERVICAL SYSTEM. THE SURGEON CONFIRMED X-RAY THAT THE BLOCKER (C2 RIGHT) LOOSENED. THEREFORE, THE SURGEON IS MONITORING FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377429 OASYS BLOCKER IMPLANT-BLOCKER MNI STRYKER SPINE-FRANCE CTW

    Patients

    Seq Age Sex Outcome Treatment
    1