BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

    MDR report key: 6197498 · Received December 22, 2016

    Report

    Report Number
    1030489-2016-03466
    Event Type
    Injury
    Date Received
    December 22, 2016
    Report Date
    January 23, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    NEUROLOGICAL SYMPTOM WAS DEVELOPED WHICH WOULD LEAD TO THE REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT WITH LUMBAR CANAL STENOSIS UNDERWENT SURGERY IN WHICH THE SPACER WAS IMPLANTED. THE SURGEON REPORTED THAT METALLOSIS WAS OBSERVED IN PATIENT AFTER THE REMOVAL OF THE SPACER. THE HOSPITAL¿S INSPECTION REVEALED THE SUSPICION OF METAL COMPONENT. THE CONTAMINATED PART WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849090 PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention