BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 2961128 · Received February 8, 2013

    Report

    Report Number
    3006179046-2013-00002
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ELLIPSE TECHNOLOGIES INC.
    Product Code
    HSB
    PMA / PMN Number
    K101997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND A NEW PRECISE INTRAMEDULLARY LIMB LENGTHENING ROD WAS IMPLANTED IN THE PT. TO DATE, THE PT IS DOING FINE. COMPLAINT INVESTIGATION SUMMARY: THE EXPLANTED DEVICE WAS DELIVERED TO ELLIPSE ON (B)(4) 2013. UPON RECEIPT, THE DEVICE WAS DECONTAMINATED. A VISUAL INSPECTION INDICATED THAT THE DISTRACTION ROD COULD BE MANUALLY EXTENDED; NO DAMAGE TO THE SURFACE OF THE ACTUATOR WAS OBSERVED. THE ACTUATOR WAS DISASSEMBLED AT THE MIDDLE WELD OF THE DEVICE; IT WAS REVEALED THAT THE WELD BETWEEN THE LEAD SCREW DRIVE STAGE AND THE LEAD SCREW COUPLER WITHIN THE ACTUATOR OF THE COMPONENT INSIDE THE PRECISE IMPLANT WAS BROKEN. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE DEVICE WAS WITHIN SPECIFICATIONS AT THE TIME OF MANUFACTURE. IN ADDITION, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    THE DEVICE WAS INITIALLY IMPLANTED IN THE PT ON (B)(6) 2012. THE DOCTOR ALLEGED THAT DURING A PT'S TWO (2) WEEK FOLLOW UP APPOINTMENT, NO DISTRACTION COULD BE SEEN WITHIN THE ACTUATOR. THE DOCTOR ATTEMPTED TO DISTRACT THE DEVICE IN THE OFFICE; HOWEVER, THE IMPLANT DID NOT APPEAR TO LENGTHEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54696 PRECISE INTRAMEDULLARY LIMB LENGTHENING ROD INTRAMEDULLARY ROD HSB ELLIPSE TECHNOLOGIES INC. LAA2-065 A120712-06

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other