BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE WAVE STAXX PEEK EXPANDABLE INTERVERTEBRAL DEVICE

    MDR report key: 17529305 · Received August 12, 2023

    Report

    Report Number
    MW5136234
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    August 29, 2012
    Report Date
    October 21, 2016
    Manufacturer
    SPINE WAVE
    Product Code
    MQP
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEDICLE SCREWS LOOSENED. A PATIENT EXPERIENCED LOW BACK PAIN AND BILATERAL LOWER EXTREMITY PAIN. ON (B)(6) 2012, THE PATIENT UNDERWENT NON SEGMENTAL PEDICLE SCREW FIXATION AT L4-L5 WITH MATRIX RODS, CONNECTING PEDICLE SCREWS AND CAPS. THE APPROACH WAS A RIGHT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) USING COMPETITOR SPINE WAVE STAXX PEEK EXPANDABLE INTERVERTEBRAL DEVICE. SUBSEQUENTLY, THE PATIENT FELT THAT THERE WAS SOMETHING FLOATING IN HIS BACK. IT WAS REPORTED THAT THE HARDWARE HAD FAILED AND "FELL APART LIKE SCAFFOLDING". ON (B)(6) 2014, ALL DEVICES WERE REMOVED. IT WAS REPORTED THAT A SPECIAL INSTRUMENT WAS UTILIZED TO REMOVE THE LOOSE PEDICLE SCREWS AND COMPETITOR'S BROKEN INTERVERTEBRAL DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PATIENT UNDERWENT FUSION OF L4-L5. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192134 SPINE WAVE STAXX PEEK EXPANDABLE INTERVERTEBRAL DEVICE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP SPINE WAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown