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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 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material deformation 337
Break 334
Mechanical issue 176
Device operates differently than expected 127
Bent 76
No Known Device Problem 73
Computer software issue 68
Device Issue 62
Device or device component damaged by another device 61
Material integrity issue 59
Imprecision 52
Unintended movement 48
No Information 38
Use of Device Issue 38
Detachment of device or device component 34
Device clogged 31
Detachment of device component 31
Fracture 27
Device displays error message 26
Material twisted 23
Electrical issue 20
Vibration 20
Device inoperable 19
Temperature issue 19
Disassembly 17
Malposition of device 15
Communication or transmission issue 15
Failure to fire 14
Positioning Issue 14
Device Cleaning Issue 14
Naturally worn 12
Application interface becomes non-functional or program exits abnormally 11
Blockage within device or device component 11
Material fragmentation 10
Dislodged or dislocated 10
Unstable 9
Smoking 8
Overheating of device or device component 8
Foreign material present in device 8
Noise, Audible 8
Computer operating system issue 7
Occlusion within device 7
Loose or intermittent connection 7
Migration of device or device component 6
Misassembled 6
Expiration date error 6
Improper or incorrect procedure or method 6
Connection issue 6
Human-Device Interface Issue 6
Improper device output 6
Mechanical jam 5
Output issue 5
Component missing 5
Metal shedding debris 5
Material separation 5
Device stops intermittently 4
Disconnection 4
Loss of or failure to bond 3
Physical resistance 3
Obstruction within device 2
Fitting problem 2
No device output 2
Incorrect or inadequate result 2
Loss of power 2
Size incorrect for patient 2
Component falling 2
Contamination during use 2
Power source issue 2
Not Applicable 2
Mechanics altered 2
Calibration issue 2
Electrical shorting 2
Patient Data Issue 2
Device handling issue 2
Environmental Particulates 1
Device markings issue 1
Incorrect device or component shipped 1
Device packaging compromised 1
Device sensing issue 1
Device-device incompatibility 1
Osseointegration issue 1
Material Protrusion 1
No code available 1
Data Issue 1
Packaging issue 1
Crack 1
Fluid leak 1
Failure to conduct 1
Calibration error 1
Circuit Failure 1
Poor quality image 1
Device abrasion from instrument or another object 1
Device emits odor 1
Difficult to position 1
Incorrect measurement 1
Material frayed 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Slippage of device or device component 1
Total Device Problems 2141

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 0
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 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 OMNI LIFE SCIENCE III Nov-17-2016
14 Smith & Nephew Inc II Nov-18-2010
15 Zimmer CAS II Jun-02-2015

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