BEUDAMED
    175 results · 51ms · Sources: EU EUDAMED, US FDA

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    LCC - PEEK 5 DEGREES MEDIUM SPACER - 10MM X 20MM X 8MM

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code MQP·February 12, 2015

    KYPHX INFLATABLE BONE TAMP

    FDA Adverse Event
    Injury ·MEDTRONIC SPINE LLC·Product code HRX·September 24, 2010

    DEVICE FOR SPINAL SURGERY FOR 1180 (EU)

    FDA Adverse Event
    Injury ·HOLGER ULLRICH·Product code FWZ·July 13, 2018

    LUCEA 50

    FDA Adverse Event
    Injury ·MAQUET SAS·Product code FSY·January 26, 2018

    NEXUS® BONESCALPEL® 25MM BLUNT BLADE AND IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·September 4, 2024

    2953769-2011-00016

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NDN·February 14, 2011

    X-STOP IPD SYSTEM

    FDA Adverse Event
    Other ·MEDTRONIC SPINE LLC.·Product code NQO·August 26, 2009

    ARTIFICIAL CERVICAL DISC

    FDA Adverse Event
    Injury ·SPINAL KINETICS LLC·Product code MJO·June 30, 2020

    OT ULTRA EASY

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·August 30, 2010

    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·March 4, 2015

    ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

    FDA Enforcement
    Class II ·Terminated·Aesculap, Inc.·July 31, 2013

    MW5080740

    FDA Adverse Event
    Injury ·October 22, 2018

    Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code NKB·November 30, 2012

    NEXUS® BONESCALPEL® 20MM, BLUNT BLADE + IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·October 25, 2024

    NEXUS® STANDARD HANDPIECE

    FDA Adverse Event
    Injury ·MISONIX, INC.·Product code LFL·July 18, 2023

    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.

    FDA Recall
    Terminated ·Ebi, Llc·Product code MAX·April 9, 2013

    NEXUS® BONESCALPEL® 20MM, UNI-LATERAL SERRATED BLADE + IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·November 6, 2024

    NEXUS® BONESCALPEL® MIS 10 MM BLADE AND SHEATH + IRRIGATION TUBING KIT

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·November 6, 2024

    PALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    FDA Recall
    Terminated ·Valorem Surgical LLC·Product code MNI·June 21, 2017

    PALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

    FDA Recall
    Terminated ·Valorem Surgical LLC·Product code MNI·June 21, 2017