BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD

    MDR report key: 5757102 · Received June 28, 2016

    Report

    Report Number
    3006179046-2016-00021
    Event Type
    Injury
    Date Received
    June 28, 2016
    Report Date
    June 1, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K141023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT'S PRECICE NAIL (LOT# A150319-08-0AA) WAS REMOVED AFTER APPROXIMATELY ONE (1) WEEK OF IMPLANTATION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE PRECICE NAIL ON (B)(6) 2016. THE NAIL WAS REMOVED ON (B)(6) 2016 AND REPLACED WITH LOT# A151216-10-0AA. IT WAS ALSO REPORTED THAT LOT# A151216-10-0AA WAS REMOVED AFTER THREE (3) WEEKS OF IMPLANTATION; THE NAIL ALLEGEDLY APPEARED TO NOT BE LENGTHENING. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE PRECICE NAIL ON (B)(6) 2016. THE PATIENT HAD A KNEE FUSION IN 2011, AND BONE AT THE DISTAL END OF THE CONSTRUCT WAS "ABNORMALLY DENSE." THE NAIL WAS REMOVED ON (B)(6) 2016 AND THE PATIENT WAS IMPLANTED WITH A NEW PRECICE NAIL WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND IS CONTINUING THEIR LENGTHENING TREATMENT WITH PRECICE; NO NEGATIVE OUTCOMES HAVE BEEN REPORTED. A DHR REVIEW OF BOTH DEVICES REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS, AND THAT THE DEVICES WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT'S PRECICE NAIL WAS REMOVED AFTER APPROXIMATELY ONE (1) WEEK OF IMPLANTATION.THE NAIL WAS REMOVED AND REPLACED WITH A NEW PRECICE NAIL (LOT# A151216-10-0AA). IT WAS ALSO REPORTED THAT LOT# A151216-10-0AA WAS REMOVED AFTER APPROXIMATELY THREE (3) WEEKS OF IMPLANTATION; THE NAIL ALLEGEDLY APPEARED TO NOT BE LENGTHENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411477 PRECICE® INTRAMEDULLARY LIMB LENGTHENING ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. P10.7-80A365, P10.7-80D365 A150319-08-0AA, A151216-10-0AA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization