BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNC14 DISTRACTION PINS

    MDR report key: 15233348 · Received August 15, 2022

    Report

    Report Number
    MW5111476
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    August 10, 2022
    Report Date
    August 11, 2022
    Manufacturer
    SYNERTECH LTD
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THREE (3) DISTRACTION PINS BROKE OFF INTO THE CERVICAL SPINE BONE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819410 SYNC14 DISTRACTION PINS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNERTECH LTD 100004/1 B2102071
    2819411 SYNC14 DISTRACTION PINS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNERTECH LTD 100004/1
    2819412 SYNC14 DISTRACTION PINS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNERTECH LTD 100004/1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male