BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL FIXATION SYSTEM

    MDR report key: 296347 · Received September 15, 2000

    Report

    Report Number
    2184052-2000-00010
    Event Type
    Injury
    Date Received
    September 15, 2000
    Date of Event
    August 15, 2000
    Report Date
    September 15, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BODY OF ONE OF THE POLYAXIAL ASSEMBLIES SEPARATED FROM THE SCREW APPROXIMATELY ONE MONTH POST-OP. THE CONSTRUCT WAS EXPLANTED AND THE PT WAS REVISED WITH ANOTHER PEDICLE SCREW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ SULZER SPINE-TECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention