BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 8109428 · Received November 28, 2018

    Report

    Report Number
    1030489-2018-01566
    Event Type
    Injury
    Date Received
    November 28, 2018
    Report Date
    July 24, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    UDI-DI
    00613994241160
    PMA / PMN Number
    K063100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 3120517, QTY: 3) (PRODUCT ID: 3120318, QTY: 1) AND (PRODUCT ID: 3125517, QTY : 2). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. PRODUCT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    POST-OP X-RAYS OF C4-C7 ACDF SHOW A BACKED OUT SCREW AT C7. SOLID FUSION IS APPARENT AT C5-6, LESS SO AT C6-7 PEEK INTERBODY GRAFTS WERE USED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULTS: THE SCREW HAS BROKEN 10MM FROM THE TIP. BOTH SECTIONS OF THE SCREW HAVE BEEN RETURNED. A MICROSCOPIC REVIEW OF THE FRACTURE SHOWS THE AREA OF CRACK PROPAGATION ALONG WITH FATIGUE LINES AND A SHEER LIP. THESE FACTORS ARE IN LINE WITH ONE ANOTHER AND ARE CONSISTENT WITH CYCLIC FATIGUE LEADING TO A MATERIAL OVERLOAD. 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-OPERATIVELY DIAGNOSED WITH NON UNION AND UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY AT C4-7 LEVELS. POST-OPERATIVELY, A SCREW WAS BROKEN IN THE BODY OF C7. AS A RESULT, THE BROKEN PORTION OF THE SCREW WAS CAPTURED AND REMOVED FROM THE C7 VERTEBRAL BODY. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE SCREW REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953374 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK 00613994241160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention