BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE SPINAL SYSTEM

    MDR report key: 278733 · Received May 18, 2000

    Report

    Report Number
    2184052-2000-00003
    Event Type
    Injury
    Date Received
    May 18, 2000
    Date of Event
    May 5, 2000
    Report Date
    May 18, 2000
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO THE SURGEON'S DETERMINATION THAT THE PT HAD NOT FUSED SINCE THE ORIGINAL SURGERY, APPROX NINE MONTHS EARLIER. DURING THE REVISION PROCEDURE, IT WAS NOTED THAT ONE OF THE LOCKING NUTS WAS VERY LOOSE AND APPEARED TO HAVE NEVER BEEN FULLY TIGHTENED. THE SILHOUETTE CONSTRUCT WAS REMOVED AND THE PT WAS REVISED WITH ANOTHER PEDICLE SCREW SYSTEM. NO COMPLICATIONS HAD BEEN REPORTED BY THE PT PRIOR TO THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SYNTHES FEMORAL RING ALLOGRAFT SPACER,| (ANTERIOR APPROACH) 1999.