BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXP PEEK ROD LRD BA 5.5X40

    MDR report key: 8349684 · Received February 19, 2019

    Report

    Report Number
    1526439-2019-51358
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 1, 2019
    Report Date
    January 23, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    NKB
    UDI-DI
    10705034130422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. WITHOUT THE RETURN OF THE DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS NO SYSTEMIC TRENDS WERE FOUND, 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

    IT WAS REPORTED THAT DR. (B)(6)'S PATIENT REPORTED INCREASED BACK ACHE, AND AFTER GOING IN TO CHECK THE SYSTEM, THE ROD ON THE RIGHT SIDE HAD SNAPPED CLOSE TO THE HEAD OF THE SCREW. HE REMOVED THE SCREWS AND REPLACED IT WITH A MEDTRONIC SCREW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144977 EXP PEEK ROD LRD BA 5.5X40 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SPINE INC 10705034130422

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention