BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 7306923 · Received March 1, 2018

    Report

    Report Number
    1030489-2018-00302
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    October 28, 2017
    Report Date
    April 13, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    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 PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465 ,510K# K050082 AND UPN# (B)(4) IS APPROVED FOR SALE IN US. H6:NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    BELOW LOT NUMBERS WERE PROVIDED BUT IT IS UNKNOWN WHICH IS THE CORRECT LOT NUMBER OF THE PRODUCT. 0564547W, 0566191W, 0575203W, 0575205W, 0581616W. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: CSM IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2017. POST-OP, THE LAMINAR SCREW AT C6 BACKED OUT. REVISION SURGERY WAS PERFORMED WHERE THE SCREW WAS REMOVED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151129 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0564547W

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention