BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2872457 · Received December 13, 2012

    Report

    Report Number
    2520274-2012-03923
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, 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

    PATIENT WAS IMPLANTED WITH CONNECTORS, RODS, HOOKS, AND SCREW CONSTRUCT ON (B)(6) 2010. PATIENT REPORTED TENDERNESS AND BACK PAIN ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2012. SURGEON SUSPECTED INFECTION AT THE IMPLANT SITE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. IT WAS NOT REPLACED WITH ANY OTHER HARDWARE. THIS IS 10 OF 22 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CONNECTORS, RODS, HOOKS, AND SCREW CONSTRUCT ON (B)(6) 2010. PATIENT REPORTED TENDERNESS AND BACK PAIN ON AN UNKNOWN DATE, APPROXIMATELY (B)(6) 2012. SURGEON SUSPECTED INFECTION AT THE IMPLANT SITE. PATIENT RETURNED TO THE OR ON (B)(6) 2012 AND ALL HARDWARE WAS REMOVED. IT WAS NOT REPLACED WITH ANY OTHER HARDWARE. THIS IS 10 OF 22 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention SCREWS, RODS, CONNECTORS, HOOKS