BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEGIS PLATE ASSEMBLY, 21MM

    MDR report key: 2595970 · Received August 14, 2009

    Report

    Report Number
    1526439-2009-00124
    Event Type
    Injury
    Date Received
    August 14, 2009
    Date of Event
    August 16, 2007
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REGULATORY COMPLIANCE DEPT WAS MADE AWARE OF AN ARTICLE IN (B)(6) (COUPLE SEEKS DAMAGES AFTER SURGERY (B)(6) 2009) THAT DETAILS AN ADVERSE OUTCOME TO A CASE INVOLVING DEPUY SPINE'S AEGIS SYS. THE ARTICLE STATES THAT THE IMPLANT WAS PLACED IN A PT. THREE DAYS LATER THE PT TOOK A SHOWER UNATTENDED HEARD A POP AND HAD SEVERE PAIN THAT WAS LATER TRACED TO A FRACTURED TAIL BONE. IT IS NOT KNOWN AT THIS TIME HOW OR IF THE AEGIS DEVICE FAILED HOWEVER AS AN AE WAS REPORTED WE ARE TAKING A CONSERVATIVE STAND AND DOCUMENTING THIS ON MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEGIS PLATE ASSEMBLY, 21MM SPINAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention AEGIS SCREW: (B)(4) (2)| AEGIS SCREW: (B)(4) (2)