BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESIDUAL LIMB LENGTHENING SYSTEM

    MDR report key: 5837909 · Received August 1, 2016

    Report

    Report Number
    3006179046-2016-00020
    Event Type
    Injury
    Date Received
    August 1, 2016
    Report Date
    July 6, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K141739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED DEVICES REVEALED THAT THERE WAS NO DAMAGE OBSERVED ON EITHER NAIL. FUNCTIONAL TESTING OF THE RLL NAILS REVEALED THAT BOTH DEVICES WERE ABLE TO BE DISTRACT AND RETRACT WHEN TESTED WITH A HIGH SPEED MAGNET TOOL, AND MET STROKE AND DISTRACTION FORCE SPECIFICATIONS WHEN TESTED WITH AN ERC UNIT. THE DEVICES OPERATED WITHIN SPECIFICATIONS AND WERE FULLY FUNCTIONAL; NO MALFUNCTION WAS DETECTED. A REVIEW OF THE LOT HISTORY RECORD FOR BOTH DEVICES REVEALED THAT THEY MET ALL THE REQUIRED QUALITY INSPECTIONS AND WERE RELEASED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT'S RLL NAIL (LOT# A150406-03-00; MANUFACTURE DATE 04/01/2015, EXPIRATION DATE 04/01/2017) WAS REMOVED AFTER OVER ONE (1) YEAR OF IMPLANTATION. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH REGARD TO HIS LENGTHENING PROTOCOL, AND THE PATIENT EXPERIENCED PRE-CONSOLIDATION. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE RLL NAIL ON (B)(6) 2015. THE NAIL WAS REMOVED ON (B)(6) 2016, AND REPLACED WITH LOT# A160328-01-0AA (MANUFACTURE DATE 03/01/2016, EXPIRATION DATE 03/01/2018). IT WAS ALSO REPORTED THAT LOT# A160328-01-0AA WAS REMOVED AFTER APPROXIMATELY THREE (3) WEEKS OF IMPLANTATION; THE NAIL ALLEGEDLY DID NOT LENGTHEN AFTER HAVING ACHIEVED 1CM OF LENGTH. 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 THE DEVICES WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT'S RLL NAIL WAS REMOVED AFTER APPROXIMATELY ONE (1) YEAR OF IMPLANTATION. THE PATIENT ALLEGEDLY EXPERIENCED PRE-CONSOLIDATION. THE NAIL WAS REPLACED WITH A NEW RLL NAIL; HOWEVER, IT WAS REMOVED AFTER APPROXIMATELY THREE (3) WEEKS OF IMPLANTATION. THE NAIL APPEARED TO NOT BE LENGTHENING AFTER HAVING ACHIEVED 1CM OF LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489109 RESIDUAL LIMB LENGTHENING SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. R14-100A130, R14-100A130 A150406-03-00, A160328-01-0AA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization