BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL

    MDR report key: 2894151 · Received December 27, 2012

    Report

    Report Number
    9617544-2012-00605
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 2, 2012
    Manufacturer
    STRYKER SPINE
    Product Code
    NKB
    PMA / PMN Number
    K052761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD¿L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE THIS WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    (B)(6) FROM OUR DEALER IN (B)(6) REPORTED THAT ¿GROWING ROD BREAKAGE-REVISION SURGERY AND FUSION WITH NORMAL ROD (4 RODS TECHNIQUE). THE BREAKAGE HAPPENED 18 MONTHS AFTER PRIMARY OPERATION AND THE PATIENT UNDERWENT FOR EARLY SECOND SURGERY. THE SURGEON HAD TO RE-OPERATE THE PATIENT, THE SECOND OPERATION WAS KIND OF HEAVY OPERATION AND LONG ANESTHESIA. IN THE REVISION SURGERY, THE SURGEON HAS INCREASED NUMBER OF IMPLANTS IN ORDER TO REINFORCE THE CONSTRUCT. ALSO HE HAD TO CHANGE FROM NON-FUSION TO FUSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA TITANIUM 4.5 EXTENDED CONNECTOR SMALL IMPLANT NKB STRYKER SPINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention