BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SYSTEM

    MDR report key: 7329972 · Received March 12, 2018

    Report

    Report Number
    1030489-2018-00367
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 9, 2018
    Report Date
    March 12, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 2990822, PMA/510K# K073291 AND UPN (B)(4) IS AVAILABLE FOR THE MARKET. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OP DIAGNOSED WITH SPINAL STENOSIS AND UNDERWENT UNSPECIFIED SURGERY AT L4-5. DURING SURGERY, THE IMPLANT BROKE IN TWO SECTIONS WHEN THE SURGEON IMPACTED IT IN. THE IMPLANT WAS REMOVED AND REPLACED BY ANOTHER ONE OF THE SAME SIZE WITHOUT PROBLEM. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BROKEN PART REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174516 CAPSTONE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MDT SOFAMOR DANEK PUERTO RICO MFG NA H5366158

    Patients

    Seq Age Sex Outcome Treatment
    1