BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 6957254 · Received October 18, 2017

    Report

    Report Number
    1030489-2017-02221
    Event Type
    Injury
    Date Received
    October 18, 2017
    Report Date
    November 20, 2017
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2991026, 510K # K073291, UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: NERVE COMPRESSION 1 YEAR AFTER SPONDYLODESES LEVELS IMPLANTED: L5-S1 IT WAS REPORTED THAT POST-OP, THERE WAS SOME SUBSIDENCE OF THE CAGE. PATIENT SUFFERED FROM NERVE COMPRESSION. AFTER ONE YEAR THERE WAS NOT ENOUGH FUSION BETWEEN L5-S1.

    Description of Event or Problem · 1

    THE CAGE WAS NOT EXPLANTED. THE PATIENT REPORTED COMPLICATIONS APPROXIMATELY 3 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736829 CAPSTONE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other