BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2890466 · Received December 31, 2012

    Report

    Report Number
    1030489-2012-02950
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    May 2, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L5-S1 ALIF TO TREAT PRIOR POSTERIOR L5-S1 NON-UNION. THE PATIENT WAS FOLLOWED UP WITH 5 AND 6 MONTHS POST-OP WITH "SCANNER CONTROL." THE LAST SCAN PERFORMED 10 MONTHS POST-OP. SINCE CONSULATION, TYPE OF PAIN SCIALTALGIE TRUNCATED LEFT WITHOUT CONSOLIDATION VISIBLE. SIGNS OF OSTEOLYSIS ON CTAND CONFIRMATION OF PERIPROSTHETIC OSTEOLYSIS SIGN OF CONSOLIDATION. INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention