BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXP PEEK ROD LRD BA 5.5X70

    MDR report key: 7109144 · Received December 12, 2017

    Report

    Report Number
    1526439-2017-50064
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    January 17, 2017
    Report Date
    November 17, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. 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 AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). GTIN:UNKNOWN.

    Description of Event or Problem · 1

    THIS PATIENT HAD HIS VIPER SC SPINAL FUSION SURGERY IN (B)(6) 2017. HE COMPLAINED 3 MONTHS LATER THAT SOMETHING WAS CLICKING IN HIS BACK. HE THEN CAME TO SEE DR (B)(6) LAST WEEK AND HAD AN MRI DONE. THE VIPER SC PEEK ROD HAD SNAPPED AND NEEDED TO BE CHANGED ONLY ON THE ONE SIDE. ALL THE SCREWS WERE INTACT. THE PATIENT REPORTS NO TRAUMA TO HIS BACK DURING THIS PERIOD FROM (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888122 EXP PEEK ROD LRD BA 5.5X70 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 5221840

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention