BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE

    MDR report key: 20845814 · Received December 4, 2024

    Report

    Report Number
    3010197239-2024-00002
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 21, 2024
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE SURGERY FOR DISC SPACE AT T10-T11 THE SURGEON INSERTED AND ROTATED THE DISC SHAVER. DURING THIS MANEUVER THE TIP OF THE SHAVER BROKE OFF AT THE JUNCTION OF THE SHAFT AND THE PADDLE. SURGEON MADE A DECISION TO LEAVE THE PIECE INSIDE THE PATIENT'S BODY. PER THE SURGEON IT COULD HAVE POTENTIALLY DONE DAMAGE TO THE SPINAL CORD AND THEREFORE HE PUT CEMENT AROUND IT TO SECURE IT. THE SURGERY RESUMED AS NORMAL WITH A SLIGHT DELAY. THE INSTRUMENT WAS INITIALLY WITH THE HOSPITAL ADMINISTRATION AND WAS LATER RETURNED TO CAMBER SPINE VIA THE SALES REP. AS PER THE INVESTIGATION THE PATIENT HAS A HISTORY OF SCLEROTIC BONE WHICH COULD BE POTENTIAL CAUSE FOR THE BREAKING OF THE SPACER WHEN INSERTER AND TWISTED AGAINST THE HARD BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049642 PINNACLE TLIF DISC SHAVER 7 MM LXH CAMBER SPINE TECHNOLOGIES I-OP-0021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other