BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVANNAH

    MDR report key: 15504726 · Received September 29, 2022

    Report

    Report Number
    3004893332-2022-00012
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 27, 2022
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    NKB
    UDI-DI
    00840916101947
    PMA / PMN Number
    K152920
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE REVIEW OF DHR FOR LOT #12-00407 AND 100998, IT WAS CONCLUDED THAT THE PRODUCT WAS INSPECTED AND ACCEPTED FOR USE WITH NO ASSOCIATED NONCONFORMANCE SPECIFIC TO THIS PRODUCT ISSUE. RETURNED DEVICE WAS VISUALLY INSPECTED, FUNCTIONALLY TESTED AND THE COMPLAINT WAS CONFIRMED. THE DEVICES WERE FRACTURED APPROXIMATELY THREE THREADS FROM THE NECK. THE RETURNED DEVICES OTHERWISE MEET DIMENSIONAL SPECIFICATIONS EXCEPT IN DAMAGED AREAS WHICH COULD NOT BE MEASURED. THOUGH THE SEGMENT IS FUSED, THE SCREWS FRACTURED DURING THE SIX YEARS OF IMPLANTATION. IT IS INCONCLUSIVE IF SUBSEQUENT SURGICAL INTERVENTION WAS REQUIRED AS THE SEGMENT WAS REPORTEDLY FUSED. UNKNOWN FACTORS INCLUDE: THE EFFECTS OF IMPLANT DURATION OF SIX YEARS, THE PROGRESSION TOWARDS SPINAL FUSION WHEN THE EVENT OCCURRED, THE DEGREE OF SPINAL INSTABILITY, PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY OR PATIENT COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT. ROOT CAUSE OR SPECIFIC FAILURE MODE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT PLIF SURGERY PRIOR TO FEBRUARY 2016 (BASED ON HISTORICAL SALES DATA) TO FUSE L5-S1. RECENTLY PATIENT HAD LOW BACK PAIN RADIATING TO BILATERAL LOWER EXTREMITIES. ON (B)(6) 2022 CT NOTED SPONDYLOLISTHESIS AT L4-L5 AND MODERATE CENTRAL STENOSIS. RADIOGRAPHS DEPICTED BILATERAL SCREW FRACTURES AT S1. PATIENT HAD FUSED L5-S1, BUT WAS REVISED FOR ADJACENT SEGMENT DISEASE, INVOLVING L3-L5 ALIF, L4-L5 LAMINECTOMY, AND L3-L5 POSTERIOR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2930161 SAVANNAH THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINAL ELEMENTS, INC 10-02-6540-2 100998_12-00407 00840916101947

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female