BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 3375192 · Received September 30, 2013

    Report

    Report Number
    3006179046-2013-00021
    Event Type
    Injury
    Date Received
    September 30, 2013
    Report Date
    August 28, 2013
    Manufacturer
    ELLIPSE TECHNOLOGIES, INCORPORATED
    Product Code
    HSB
    PMA / PMN Number
    K113219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED BILATERALLY WITH PRECICE NAILS FROM DIFFERENT LOT NUMBERS, ONE (1) NAIL WAS FROM LOT NUMBER A120712-07 AND THE OTHER NAIL WAS FROM LOT NUMBER A120606-01. THE DOCTOR DID NOT IDENTIFY WHICH LOT NUMBER WAS IMPLANTED IN THE PATIENT'S RIGHT TIBIA; THEREFORE, THE LOT NUMBER OF THE SUSPECT MEDICAL DEVICE REQUESTED WAS LEFT BLANK. THE PATIENT HAD COMPLETED THEIR LENGTHENING TREATMENT AND WAS IN THE CONSOLIDATION PHASE WHEN THE PRECICE NAIL ALLEGEDLY BROKE. THE PRECICE NAIL WAS REMOVED, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW OF BOTH OF THE LOTS REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT BOTH OF THE DEVICES WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT AFTER APPROXIMATELY NINE (9) MONTHS AFTER IMPLANTATION, A BILATERAL PATIENT'S RIGHT TIBIAL PRECICE NAIL ALLEGEDLY BROKE. THE PATIENT HAD COMPLETED THEIR LENGTHENING TREATMENT AND WAS IN THE CONSOLIDATION PHASE WHEN THE PRECICE NAIL ALLEGEDLY BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492021 PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ELLIPSE TECHNOLOGIES, INCORPORATED LAA1-065

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other