BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS SCREWS AND INSTR

    MDR report key: 5483002 · Received March 7, 2016

    Report

    Report Number
    1030489-2016-00611
    Event Type
    Injury
    Date Received
    March 7, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 10, 2016
    Manufacturer
    MDT SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PMA 510(K): THE PART NUMBER G876H015 IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH 510K NUMBER K970806 IS APPROVED TO BE MARKETED IN THE US. NEITHER PRODUCT NOR APPLICABLE IMAGING STUDIES WERE RETURNED FOR EVALUATION. HENCE, IT IS DIFFICULT TO DRAW ANY CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT ACP SURGERY FOR OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT AT C2-C6 (C3/4: CORPECTOMY). POST-OP, A PLATE AT C5/6 WAS DISLOCATED. REVISION SURGERY WAS PERFORMED (POSTERIOR FUSION) AT C2/7 DUE TO INSTABILITY AND THE SURGEON USED SAME 100MM PLATE AND REPLACED SCREW TO 4.5MM SIZE SCREW. THE SURGEON COMMENTED OSSIFICATION OF ANTERIOR LONGITUDINAL LIGAMENT (ALL) WAS OBSERVED AND HE USED LONG SCREW BUT THE 15MM SCREW WAS THE LONGEST SO IT COULD NOT BE TIGHTENED MUCH. THE PRODUCTS CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139141 ATLANTIS SCREWS AND INSTR APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE