BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASYS BLOCKER

    MDR report key: 5254005 · Received November 30, 2015

    Report

    Report Number
    3004024955-2015-00098
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 3, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING ENTITY: STRYKER SPINE-(B)(4). CATALOG# 48551000, LOT# JBP. DATE OF IMPLANT: (B)(6) 2015; DATE OF EXPLANT: (B)(6) 2015. PMA/510K # : K032394. METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE RETURNED DEVICE WAS CONFIRMED VIA THE XRAY TO HAVE A BLOCKER THAT BACKED OUT OF THE POLYAXIAL SCREW HEAD. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED AS ALL RELEASED UNITS MET STRYKER SPECIFICATIONS. CONCLUSION: THE LIKELY ROOT CAUSE IS NOT DETERMINED DUE TO LACK OF DETAILS AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT; OASYS SET SCREWS POPPED OUT OF C1 SCREWS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT; OASYS SET SCREWS POPPED OUT OF C1 SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785725 OASYS BLOCKER SPINAL INTERLAMINAL FIXATION ORTHOSIS. KWP STRYKER SPINE-FRANCE JBP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention