1,771 results
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33ms
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Sources: EU EUDAMED, US FDA
MW5080740
FDA Adverse Event
Injury
·October 22, 2018
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.
FDA Enforcement
Class II
·Terminated·Lanx, Inc.·December 4, 2013
LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.
FDA Recall
Terminated
·Lanx, Inc.·Product code OVD·November 4, 2013
LANX ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC·Product code KWQ·January 18, 2012
LANX POSTERIOR CERVICOTHORACIC SFS
FDA Adverse Event
Other
·LANX, INC.·Product code MNI·February 13, 2012
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code MNI·January 23, 2012
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code KWP·January 27, 2012
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC.·Product code MNI·January 17, 2012
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code KWP·February 19, 2009
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code MNI·April 3, 2014
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code JDN·January 15, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code KWQ·April 15, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC·Product code KWQ·May 28, 2010
LANX INTERVERTEBRAL BODY FUSION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code MAX·June 14, 2010
LANX ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·LANX, INC·Product code KWQ·June 17, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC·Product code KWQ·May 15, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC·Product code KWQ·May 3, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC·Product code KWQ·May 15, 2010
LANX SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·LANX, INC.·Product code KWQ·June 24, 2010
LANX FUSION SYSTEM
FDA Adverse Event
Malfunction
·LANX, INC.·Product code MAX·December 20, 2012