BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE

    MDR report key: 11704042 · Received April 21, 2021

    Report

    Report Number
    3004893332-2021-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 30, 2021
    Report Date
    March 30, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    KWQ
    UDI-DI
    00840606107792
    PMA / PMN Number
    K101848
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW CANNOT BE COMPLETED AT THIS TIME AS THE PRODUCT WAS NOT RETURNED AND A LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED AND THEREFORE COULD NOT BE EVALUATED. UNKNOWN FACTORS INCLUDE: PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT, PATIENT BONE QUALITY, THE DEGREE OF SPINAL INSTABILITY, PATIENT COMPLIANCE WITH POSTOPERATIVE CARE INSTRUCTIONS, OR IF THE PATIENT SUSTAINED A FALL/IMPACT OF ANY SORT. ROOT CAUSE OF SPECIFIC FAILURE MODE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019 PATIENT UNDERWENT CERVICAL FUSION SURGERY WITH A VBR AT C6, SINGLE LEVEL ACDF AT C4-C5 AND ANTERIOR CERVICAL PLATE (ACP) C4-C7. REPORTEDLY ON (B)(6) 2021 RADIOGRAPHS DEPICTED THE LEFT C7 BONE SCREW ON THE ACP HAD BACKED OUT. ON (B)(6) 2021 EVISION SURGERY WAS PERFORMED TO REPLACE THE C7 SCREW AND AN ADDITIONAL STAND-ALONE ACDF AT C3-C4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600654 SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINAL ELEMENTS, INC 26240-014 00840606107792

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention