BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01510

    MDR report key: 3010175 · Received March 19, 2013

    Report

    Report Number
    2520274-2013-01510
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 NON-SYNTHES PEDICLE SCREWS, NON-SYNTHES ROD, AND TWO SYNTHES PEEK SPACERS ON (B)(6) 2011 FOR AN ANTERIOR LUMBAR FUSION AT L4-L5, L5-S1. PATIENT COMPLAINED OF SEVERE IRRITATION. PATIENT PRESENTED TO SURGEON WITH ONGOING UNKNOWN IRRITATION AND INFLAMMATION. IT WAS REPORTED THE PATIENT WAS RETURNED TO THE O. R. ON (B)(6) 2013 FOR REMOVAL OF THE COMPETITOR'S PEDICLE SCREWS AND ROD. THE TWO PEEK IMPLANTS REMAINED INTACT AND IMPLANTED. THE PATIENT'S FUSION WAS REPORTEDLY GOOD. THE PATIENT INDICATED THAT THE IRRITATION AND INFLAMMATION IS IMPROVING, AND HE PLANS TO BEGIN PHYSICAL THERAPY ON (B)(6) 2013. PATIENT HAS SEEN AN ALLERGIST AND RESULTS OF PATCH TEST INDICATE SENSITIVITY TO SEVERAL MATERIALS. AT THE RECOMMENDATION OF THE ALLERGIST, THE PATIENT REQUESTED MATERIAL COMPOSITION OF PEEK IMPLANTS. THIS REPORT IS FOR AN UNKNOWN PEEK SPACER. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114879 MQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention COMPETITORS ROD AND SCREWS