BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXP PEEK ROD LRD BA 5.5X70

    MDR report key: 7109037 · Received December 12, 2017

    Report

    Report Number
    1526439-2017-50063
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    October 3, 2016
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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.

    Description of Event or Problem · 1

    IT WAS IMPLANTED 6 SCREWS, 2 RODS AND CAGE TO THE PATIENT. THE PATIENT CAME TO THE CLINIC WITH BACK PAIN. THE PATIENT DID X-RAYS WHICH SHOWED A BROKEN ROD. AFTER THE OPERATIVE EXPLORATION WERE REMOVED 4 SCREWS AND A BROKEN ROD. THIS COMPLAINT ON THE FRACTURE OF THE ROD WITH TRANSPEDICULAR FIXATION OF THE LUMBAR SPINE, PROBABLY CAUSED BY THE IMPROPER OPERATION DURING THE POSTOPERATIVE PERIOD. THE PRODUCT CODE IS 186782070 LOT N/A NO HARM TO THE PATIENT, WE WILL PEOVIDE X-RAYS AFTER THE PATIENT WILL PROVIDE CONSENT TO THE PROCESSING OF PERSONAL DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890040 EXP PEEK ROD LRD BA 5.5X70 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention