BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON LEGACY SPINAL SYSTEM

    MDR report key: 9951640 · Received April 11, 2020

    Report

    Report Number
    1030489-2020-00435
    Event Type
    Injury
    Date Received
    April 11, 2020
    Report Date
    April 11, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOUTHERS C, ET AL. OUTCOMES AT SKELETAL MATURITY OF 34 CHILDREN WITH SCOLIOSIS TREATED WITH A TRADITIONAL SINGLE GROWING ROD. SPINE. 2019; 44(23):1630-1637. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ABSTRACT THAT 34 CHILDREN (25 GIRLS AND 9 BOYS) CHILDREN WITH A MEDIAN AGE OF 11.7 YEARS AND WITH SKELETAL IMMATURITY WERE TREATED. THESE CHILDREN WERE TREATED INITIALLY WITH A TRADITIONAL SINGLE GROWING ROD AND WERE FOLLOWED UP UNTIL THEY REACHED SKELETAL MATURITY. IN THE SURGICAL METHOD, A SINGLE 5.5 MM TITANIUM ROD WAS ATTACHED TO THE SPINE WITH THREE HOOKS PROXIMALLY AND TWO MONOAXIAL PEDICLE SCREWS DISTALLY. MEDIAN FOLLOW-UP WAS 6.5 YEARS. AMONG THE PATIENT COMPLICATIONS, 26 CASES FOR ROD FRACTURES IN 14 PATIENTS, 1 CASE OF IMPLANT PROMINENCE, 2 CASES OF PROXIMAL HOOK DISLODGEMENT, AND 2 CASES OF WOUND INFECTIONS WERE OBSERVED. FOR ALL THE AFOREMENTIONED 31 EVENTS OBSERVED IN 16 PATIENTS, UNPLANNED SURGERIES WERE PERFORMED. THE FIRST EPISODE OF ROD FRACTURE OCCURRED AT A MEDIAN 3.8 YEARS AFTER INDEX SURGERY. SINGLE GROWING ROD WAS EXCHANGED IN 16 CASES OCCURRING IN 4 SKELETALLY IMMATURE PATIENTS. FOR 10 CASES OCCURRING AT TREATMENT COMPLETION, 3 POSTERIOR SPINAL FUSION, 1 DEFINITIVE GROWING ROD REMOVAL, AND 6 DUAL GROWING ROD SURGERIES WITHOUT FURTHER DISTRACTION WERE PERFORMED. NO GROWING ROD FRACTURE OCCURRED AFTER ADDITION OF A SECOND GROWING ROD AT END OF GROWTH. POSTERIOR JUNCTIONAL KYPHOSIS WAS ALSO REPORTED IN 4 PATIENTS, ONE IDIOPATHIC AND THREE SYNDROMIC. BONY FRAGILITY MAY HAVE BEEN THE LEADING CAUSE. PATIENTS WERE ASYMPTOMATIC HENCE NOT REVISED. FINAL TREATMENT FOR THOSE PATIENTS WAS THREE POSTERIOR SPINAL FUSION AND ONE DUAL GROWING ROD SURGERY. TWO PATIENTS HAD A POSTOPERATIVE COMPLICATION AFTER THEIR POSTERIOR SPINAL FUSION (ONE POSTOPERATIVE HEMATOMA, ONE DEEP WOUND INFECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414735 CD HORIZON LEGACY SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention