BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USS CONSTRUCT

    MDR report key: 2971688 · Received February 21, 2013

    Report

    Report Number
    2520274-2013-01079
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED IN (B)(6) 2011 FOR T8-ILIUM DEGENERATIVE SCOLIOSIS WITH SYNTHES USS AND VERTEBROPLASTIES AT T6-T7 LEVELS, AND USING DEPUY CONFIDENCE SPINAL CEMENT. PATIENT PRESENTED TO ER ON (B)(6) 2012 WITH NEUROLOGICAL DEFICITS AND HAD DEVELOPED SIGNIFICANT KYPHOSIS AT THE T7 LEVEL. X-RAYS ON (B)(6) 2012 SHOWED SIGNIFICANT COLLAPSE OF THE T7 VERTEBRAL BODY, AND THAT MOST OF THE SPINAL CEMENT IN THE T7 VERTEBRAL BODY WAS NO LONGER PRESENT IN ITS ORIGINAL FORM, WHEN COMPARED TO ORIGINAL POST-OP FILMS FROM (B)(6) 2011. SURGEON RETURNED PATIENT TO OR ON (B)(6) 2012 TO DECOMPRESS THE PATIENT AND TO EXTEND THE CONSTRUCT CRANIALLY TO REDUCE THE KYPHOSIS. NO PRODUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75424 USS CONSTRUCT KWP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention DEPUY CONFIDENCE SPINAL CEMENT