BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    MDR report key: 7955368 · Received October 11, 2018

    Report

    Report Number
    1030489-2018-01348
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 11, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 5030541, 510K # K133653 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: CERVICAL SPONDYLOTIC MYELOPATHY PROCEDURE: ANTERIOR CERVICAL DISCECTOMY AND FUSION IT WAS REPORTED THAT INTRA-OP, THE IMPLANT BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE BROKEN IMPLANT WAS REPLACED WITH A NEW ONE. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795664 CORNERSTONE-SR TI-COATED CAGE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MSD DEGGENDORF MFG NA 12FT

    Patients

    Seq Age Sex Outcome Treatment
    1