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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Product CodeOLO
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 259
Material deformation 219
Device operates differently than expected 100
Mechanical issue 92
Computer software issue 55
No Known Device Problem 47
Device or device component damaged by another device 43
Bent 41
Unintended movement 36
Device Issue 33
Use of Device Issue 30
Imprecision 29
Detachment of device component 26
No Information 22
Material integrity issue 20
Vibration 20
Fracture 17
Electrical issue 16
Detachment of device or device component 15
Temperature issue 15
Failure to fire 14
Communication or transmission issue 13
Device inoperable 13
Device clogged 13
Positioning Issue 13
Device displays error message 12
Malposition of device 12
Overheating of device or device component 8
Material fragmentation 8
Noise, Audible 8
Material twisted 8
Naturally worn 8
Dislodged or dislocated 7
Device Cleaning Issue 7
Computer operating system issue 7
Expiration date error 6
Smoking 6
Misassembled 6
Metal shedding debris 5
Component missing 5
Improper device output 5
Mechanical jam 4
Output issue 4
Material separation 4
Disconnection 4
Application interface becomes non-functional or program exits abnormally 3
Occlusion within device 3
Migration of device or device component 3
Loose or intermittent connection 3
Improper or incorrect procedure or method 3
Unstable 3
Incorrect or inadequate result 2
Device stops intermittently 2
Size incorrect for patient 2
Fitting problem 2
Connection issue 2
Physical resistance 2
No device output 2
Loss of power 2
Disassembly 2
Contamination during use 2
Component falling 2
Blockage within device or device component 2
Loss of or failure to bond 2
Power source issue 2
Not Applicable 2
Patient Data Issue 2
Device handling issue 2
Mechanics altered 2
Calibration issue 2
Human-Device Interface Issue 2
Electrical shorting 2
Environmental Particulates 1
Device markings issue 1
Device packaging compromised 1
Device sensing issue 1
Device-device incompatibility 1
Material Protrusion 1
No code available 1
Data Issue 1
Packaging issue 1
Osseointegration issue 1
Calibration error 1
Circuit Failure 1
Failure to conduct 1
Failure to power-up 1
Incorrect software programming calculations 1
Difficult to remove 1
Device emits odor 1
Incorrect measurement 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Patient-device incompatibility 1
Application program issue 1
Battery issue 1
Device damaged prior to use 1
Failure to deliver 1
Failure to separate 1
Obstruction within device 1
Total Device Problems 1423

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 1 0 2 5 4
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Blue Belt Technologies MN II May-09-2014
2 Brainlab AG II Feb-26-2015
3 Mako Surgical Corporation II Apr-29-2016
4 Mako Surgical Corporation II Apr-28-2016
5 Mako Surgical Corporation II Apr-18-2016
6 Mako Surgical Corporation II Nov-05-2015
7 Mako Surgical Corporation II Feb-19-2015
8 Mako Surgical Corporation II Dec-18-2014
9 Mako Surgical Corporation II Nov-19-2012
10 Mako Surgical Corporation II Nov-01-2011
11 Medtronic Navigation, Inc. II Aug-02-2016
12 Medtronic Navigation, Inc. II Sep-30-2015
13 Smith & Nephew Inc II Nov-18-2010
14 Zimmer CAS II Jun-02-2015

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