BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVANNAH

    MDR report key: 7610113 · Received June 18, 2018

    Report

    Report Number
    1067095-2018-00002
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 9, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    NKB
    UDI-DI
    00840916102173
    PMA / PMN Number
    K132925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOGRAPH RECEIVED CONFIRMED THE REPORTED EVENT. NO PRODUCT WAS RETURNED, NO PRODUCT INFORMATION WAS GIVEN, AND NO FURTHER EVALUATION OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. PATIENT'S ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT'S COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS, PATIENT'S BONE QUALITY, AND THE DEGREE OF SPINAL INSTABILITY ARE ALL UNKNOWN. IT WAS REPORTED THAT THE PATIENT DID NOT SUSTAINED A FALL/IMPACT/TRAMA AT THE TIME OF THE EVENT. THOUGH THE DEVICES WERE LOADED FOR 19 MONTHS, AND CYCLICAL FATIGUE MAY OCCUR WITH NONUNION; THE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF LABELING NOTES. POSSIBLE ADVERSE EFFECTS: POTENTIAL ADVERSE EFFECTS MAY INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: · BENDING, DISASSEMBLY, OR FRACTURE OF ANY OR ALL IMPLANT COMPONENTS. ·DELAYED UNION OR NONUNION: INTERNAL FIXATION APPLIANCES ARE LOAD SHARING DEVICES WHICH ARE USED TO OBTAIN ALIGNMENT UNTIL NORMAL HEALING OCCURS. IN THE EVENT THAT HEALING IS DELAYED, DOES NOT OCCUR, OR FAILURE TO IMMOBILIZE THE DELAYED/NONUNION RESULTS, THE IMPLANT WILL BE SUBJECT TO EXCESSIVE AND REPEATED STRESSES WHICH CAN EVENTUALLY CAUSE LOOSENING, BENDING, OR FATIGUE FRACTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, PATIENT UNDERWENT SINGLE LEVEL SPINAL FUSION SURGERY TO FUSE L4-L5. PATIENT RECEIVED AN INTERBODY DEVICE AND BILATERAL POSTERIOR FIXATION. ON (B)(6) 2017 RADIOGRAPH NOTED THAT THE PATIENT HAD POSSIBLE OSTEOLYISIS NEAR THE TIPS OF THE PEDICLE SCREWS AT L4. THE L4 VERTEBRAL BODY HAD GRADE ONE SPONDYLOLISTHESIS AND THE L5 PEDICLE SCREWS HAD FRACTURED APPROXIMATELY AT THE SECOND THREAD BELOW THE SHANK HEAD. REVISION SURGERY WAS PERFORMED TO REPLACE THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453115 SAVANNAH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS 10-03-6550-2 00840916102173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention