BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO II SPINAL SYSTEM

    MDR report key: 6577666 · Received May 19, 2017

    Report

    Report Number
    1030489-2017-01268
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    April 26, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MNH
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE U.S., HOWEVER A LIKE DEVICE WITH PART# 8632345, 510K# K991031 AND UPN# (B)(4) IS APPROVED FOR USE IN THE US. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: IDIOPATHIC SCOLIOSIS PROCEDURE: POSTERIOR SCOLIOSIS FUSION LEVELS IMPLANTED: TH4-L3 IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SPINAL FIXATION SURGERY FOR CORRECTION USING HOOKS (FOR THORACIC) AND PEDICLE SCREWS (FOR LUMBAR). ONE WEEK POST-OP, THE HOOK PLACED ON THE MOST CRANIAL SIDE WAS BACKED OUT. IT WILL BE REPLACED WITH NEW ONE IN A RE-OPERATION. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359997 COLORADO II SPINAL SYSTEM ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION MNH WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention