BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFIX SPINAL SYSTEM

    MDR report key: 5418990 · Received February 6, 2016

    Report

    Report Number
    9617297-2016-00001
    Event Type
    Injury
    Date Received
    February 6, 2016
    Date of Event
    December 7, 2015
    Report Date
    December 22, 2015
    Manufacturer
    U&I CORP.
    Product Code
    MNH
    PMA / PMN Number
    K091725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE, U&I CORPORATION, AS THE LEGAL MANUFACTURER OF THE PERFIX SPINAL SYSTEM RECEIVED THE BROKEN ROD REMOVED FROM THE PT'S BODY. THE LOT NUMBER OF THE PRODUCT WAS VERIFIED AS 15C014-3. WE TRACED RELATED MFG DATA AND INSPECTION DATE AND EVALUATED. AS THE RESULT, NO DEFECT WAS FOUND IN THE PRODUCT QUALITY. WE HAVE REQUESTED ADD'L INFO OF THE PT AND CLINICAL DATA BUT THEY ARE NOT RECEIVED YET. WHEN RECEIVED, WE WILL EVALUATE FURTHERMORE AND CAN CONCLUDE A CAUSE OF THIS EVENT. WE WILL KEEP MONITORING ON THE SAME CUSTOMER COMPLAINT IN FUTURE AND ITS CYCLE AS WELL.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPINAL FIXATION SYSTEM WAS IMPLANTED IN A PT ON (B)(6) 2015 INITIALLY. A ROD AS A COMPONENT OF THE SYSTEM WAS BROKEN WHILE IT WAS IN THE PT'S BODY. THE PT HAD RE-SURGERY ON (B)(6) 2015 TO REMOVE THE BROKEN ROD AND REPLACE A NEW ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73612 PREFIX SPINAL SYSTEM MNH U&I CORP. 15C014-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention