BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, 480 MM

    MDR report key: 8850511 · Received August 1, 2019

    Report

    Report Number
    1526439-2019-51912
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    January 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), UNKNOWN. THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). UDI (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. ALTHOUGH LOT NUMBER WAS PROVIDED, MANUFACTURING RECORDS COULD NOT BE FOUND USING THIS LOT NUMBER. THEREFORE, WITHOUT A VALID LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. WITHOUT THE RETURN OF THE DEVICE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLE BE PROVIDED AT A LATER TIME, THIS COMPLAINT WILL BE REOPENED AND DEVICE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    EXPLANTATION OF SPINE CONSTRUCT BECAUSE OF FRACTURE OF ROD. DOI: UNKNOWN, DOR: UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# 226107, QUANTITY 1); UNKNOWN SCREW (PART # UNKNOWN, LOT # 222623, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645377 ROD, 480 MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH BDMSB51

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention