BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    MDR report key: 6847557 · Received September 7, 2017

    Report

    Report Number
    1030489-2017-02006
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 14, 2017
    Report Date
    March 3, 2018
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    ODP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS: VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED IMPLANT WAS PERFORMED. THE IMPLANT WAS CRACKED AT THE THREADED THROUGH HOLE. THERE WAS MATERIAL TRANSFER ON THE SIDES OF THE IMPLANT INDICATING THAT IT CAME IN CONTACT WITH THE BODY. GIVEN THE REPORTED EVENT AND THE VISUAL EVIDENCE, IT WOULD APPEAR THE CRACK WAS THE RESULT OF IMPACT DURING IMPLANTATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 5030564, 510K # K133653 AND (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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION"HWK".INTRA-OP, THE TITANIUM COATED CAGE WAS PLACED WITH THE INSERTER. SURGEON USED A HAMMER WITH NORMAL IMPACT. AS HE CONTROLLED THE POSITION HE SAW A LITTLE FISSURE. THE CAGE BROKE INTRA-OPERATIVE WHILE THE CAGE WAS PLACED IN THE INTERVERTEBRAL DISC SO HE REMOVED THE CAGE AND INSERTED A NEW ONE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627481 CORNERSTONE-SR TI-COATED CAGE SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP MSD DEGGENDORF MFG NA 30DE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR