BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL DEVICE

    MDR report key: 3113802 · Received May 15, 2013

    Report

    Report Number
    1526439-2013-17131
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    March 9, 2010
    Report Date
    May 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT ALERT DATE IS (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF ADDITIONAL INFORMATION, RECEIPT OF THE DEVICE, OR IF IS DETERMINED THAT NEITHER THE DEVICE NOR ADDITIONAL INFORMATION IS AVAILABLE. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. A COMPLAINT TREND ANALYSIS COULD NOT BE CONDUCTED AS A PRODUCT FAMILY, CODE OR LOT NUMBER WAS NOT IDENTIFIED. THE PROVIDED X-RAY EXAMINATION RESULTS (NO IMAGES) WERE REVIEWED BY MEDICAL DIRECTOR. IN THE ABSENCE OF IMAGES, NO CONCLUSIONS COULD BE MADE. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    Description of Event or Problem · 1

    PER INTERNATIONAL AFFILIATE, CUSTOMER REPORTS PAIN IN HER BACK/ SPINE AT SOME POINT FOLLOWING DEVICE IMPLANTATION. REQUEST HAS BEEN MADE FOR DETAILED INFORMATION REGARDING THE PATIENT, DEVICE, AND THE EVENT, FOR RETURN OF THE DEVICE, AND FOR CONFIRMATION OF THE ALERT DATE THAT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214799 UNKNOWN SPINAL DEVICE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention