BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHROS

    MDR report key: 7172457 · Received January 8, 2018

    Report

    Report Number
    3010197239-2017-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    October 31, 2017
    Report Date
    November 27, 2017
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    NKB
    UDI-DI
    B030ORO7540R0
    PMA / PMN Number
    K`133366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT OCTOBER 31, 2017. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. INDEPENDENT REVIEW OF MEDICAL RECORDS INDICATES CONTRIBUTING FACTORS INCLUDE LACK OF FUSION AT L5/ S1 VERTEBRAL BODY DUE TO MECHANICAL OVERLOAD OF THE REDUCTION PEDICLE SCREWS. FUSION OBSERVED AT L4-L5. ALL FRAGMENTS OF SCREWS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL LAMINECTOMY FOR DECOMPRESSION AT L4-S1 AND X-RAY SHOWED HARDWARE FRACTURE (2 REDUCTION SCREWS) WITH PSEUDOARTHROSIS AT L5-S1 APPROXIMATELY 6-7 MONTHS POSTOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17583 ORTHROS Ø7.5MM POLYAXIAL REDUCTION PEDICLE SCREW , 40MM LG. NKB CAMBER SPINE TECHNOLOGIES ORO-7540R B030ORO7540R0

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR