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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 196
Material deformation 172
Device operates differently than expected 89
Mechanical issue 64
Computer software issue 41
Device or device component damaged by another device 40
Bent 37
Device Issue 33
No Known Device Problem 27
Unintended movement 27
Imprecision 22
Vibration 20
No Information 20
Use of Device Issue 19
Detachment of device component 19
Failure to fire 14
Temperature issue 14
Material integrity issue 13
Device inoperable 12
Communication or transmission issue 11
Device clogged 11
Positioning Issue 11
Electrical issue 10
Device displays error message 10
Detachment of device or device component 9
Malposition of device 9
Fracture 9
Material fragmentation 8
Overheating of device or device component 8
Noise, Audible 8
Dislodged or dislocated 7
Device Cleaning Issue 7
Computer operating system issue 7
Material twisted 7
Expiration date error 6
Smoking 6
Misassembled 6
Component missing 5
Improper device output 5
Naturally worn 5
Output issue 4
Unstable 3
Metal shedding debris 3
Improper or incorrect procedure or method 3
Occlusion within device 3
Disconnection 3
Loose or intermittent connection 3
Material separation 3
Size incorrect for patient 2
Loss of power 2
Migration of device or device component 2
No device output 2
Component falling 2
Blockage within device or device component 2
Application interface becomes non-functional or program exits abnormally 2
Fitting problem 2
Incorrect or inadequate result 2
Device stops intermittently 2
Mechanical jam 2
Mechanics altered 2
Calibration issue 2
Physical resistance 2
Power source issue 2
Patient Data Issue 2
Not Applicable 2
No code available 1
Data Issue 1
Device handling issue 1
Packaging issue 1
Environmental Particulates 1
Human-Device Interface Issue 1
Connection issue 1
Device packaging compromised 1
Device-device incompatibility 1
Sticking 1
Device damaged prior to use 1
Failure to deliver 1
Failure to separate 1
Obstruction within device 1
Cut in material 1
Disassembly 1
Contamination during use 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Loss of or failure to bond 1
Circuit Failure 1
Device emits odor 1
Incorrect measurement 1
Failure to power-up 1
Incorrect software programming calculations 1
Difficult to position 1
Slippage of device or device component 1
Failure to read input signal 1
Total Device Problems 1131

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 3
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 Sep-30-2015
12 Smith & Nephew Inc II Nov-18-2010
13 Zimmer CAS II Jun-02-2015

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