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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 12
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 9
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material deformation 414
Break 377
Mechanical issue 269
Device operates differently than expected 177
No Information 133
Material integrity issue 110
No Known Device Problem 108
Bent 92
Imprecision 90
Disassembly 82
Computer software issue 77
Device Issue 63
Device or device component damaged by another device 61
Detachment of device or device component 60
Unintended movement 50
Use of Device Issue 47
Device displays error message 39
Fracture 37
Electrical issue 33
Device clogged 33
Detachment of device component 32
Communication or transmission issue 26
Material twisted 22
Vibration 21
Device inoperable 21
Loose or intermittent connection 20
Temperature issue 19
Connection issue 15
Malposition of device 15
Device Cleaning Issue 15
Migration of device or device component 14
Failure to fire 14
Positioning Issue 14
Naturally worn 13
Application interface becomes non-functional or program exits abnormally 13
Blockage within device or device component 11
Dislodged or dislocated 11
Material fragmentation 10
Unstable 10
Overheating of device or device component 9
Foreign material present in device 9
Computer operating system issue 9
Mechanical jam 8
Noise, Audible 8
Smoking 8
Occlusion within device 7
Material separation 7
Misassembled 6
Improper or incorrect procedure or method 6
Output issue 6
Human-Device Interface Issue 6
Improper device output 6
Calibration issue 6
Expiration date error 6
Device stops intermittently 5
Component missing 5
Metal shedding debris 5
Disconnection 4
Loss of or failure to bond 4
Incorrect or inadequate result 3
Application program issue 3
Physical resistance 3
Patient Data Issue 3
Device handling issue 3
Not Applicable 3
Data Issue 2
Power source issue 2
Date-related software issue 2
Patient-device incompatibility 2
Device markings issue 2
Mechanics altered 2
Electrical shorting 2
Loss of power 2
Unintended collision 2
No device output 2
Size incorrect for patient 2
Obstruction within device 2
Fitting problem 2
Component falling 2
Contamination during use 2
Crack 1
Degraded 1
Failure to conduct 1
Calibration error 1
Circuit Failure 1
Component incompatible 1
Unintended arm motion 1
Premature discharge of battery 1
Material disintegration 1
Device expiration issue 1
Fluid leak 1
Material frayed 1
Image display error 1
Incorrect measurement 1
Device abrasion from instrument or another object 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Device damaged prior to use 1
Defective component 1
Total Device Problems 2866

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 1 0 2 5 4 6
Class III 0 0 0 0 0 0 0 0 0 1 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 Jul-18-2017
4 Mako Surgical Corporation II Mar-07-2017
5 Mako Surgical Corporation II Feb-11-2017
6 Mako Surgical Corporation II Apr-29-2016
7 Mako Surgical Corporation II Apr-28-2016
8 Mako Surgical Corporation II Apr-18-2016
9 Mako Surgical Corporation II Nov-05-2015
10 Mako Surgical Corporation II Feb-19-2015
11 Mako Surgical Corporation II Dec-18-2014
12 Mako Surgical Corporation II Nov-19-2012
13 Mako Surgical Corporation II Nov-01-2011
14 Medtronic Navigation, Inc. II Aug-02-2016
15 Medtronic Navigation, Inc. II Sep-30-2015
16 OMNI LIFE SCIENCE III Nov-17-2016
17 Orthosoft, Inc. dba Zimmer CAS II Apr-26-2017
18 Orthosoft, Inc. dba Zimmer CAS II Apr-19-2017
19 Smith & Nephew Inc II Nov-18-2010
20 Zimmer Biomet, Inc. II Mar-27-2017
21 Zimmer CAS II Jun-02-2015

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