• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 214
Material deformation 188
Device operates differently than expected 92
Mechanical issue 72
Computer software issue 50
Device or device component damaged by another device 40
Bent 39
Device Issue 33
No Known Device Problem 33
Unintended movement 30
Imprecision 23
Use of Device Issue 21
No Information 21
Vibration 20
Detachment of device component 20
Failure to fire 14
Temperature issue 14
Material integrity issue 13
Communication or transmission issue 12
Device inoperable 12
Electrical issue 12
Device clogged 11
Positioning Issue 11
Fracture 10
Detachment of device or device component 10
Malposition of device 10
Device displays error message 10
Material fragmentation 8
Overheating of device or device component 8
Noise, Audible 8
Naturally worn 7
Material twisted 7
Dislodged or dislocated 7
Device Cleaning Issue 7
Computer operating system issue 7
Expiration date error 6
Smoking 6
Misassembled 6
Component missing 5
Improper device output 5
Output issue 4
Metal shedding debris 4
Disconnection 4
Occlusion within device 3
Migration of device or device component 3
Loose or intermittent connection 3
Application interface becomes non-functional or program exits abnormally 3
Improper or incorrect procedure or method 3
Unstable 3
Material separation 3
Size incorrect for patient 2
Incorrect or inadequate result 2
Device stops intermittently 2
Fitting problem 2
Physical resistance 2
Calibration issue 2
Disassembly 2
Component falling 2
Blockage within device or device component 2
No device output 2
Loss of power 2
Power source issue 2
Electrical shorting 2
Mechanical jam 2
Mechanics altered 2
Patient Data Issue 2
Not Applicable 2
No code available 1
Data Issue 1
Device handling issue 1
Material Protrusion 1
Environmental Particulates 1
Human-Device Interface Issue 1
Packaging issue 1
Osseointegration issue 1
Failure to power-up 1
Incorrect software programming calculations 1
Difficult to remove 1
Difficult to position 1
Incorrect measurement 1
Device emits odor 1
Loss of or failure to bond 1
Circuit Failure 1
Failure to conduct 1
Contamination during use 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Connection issue 1
Device packaging compromised 1
Device-device incompatibility 1
Patient-device incompatibility 1
Failure to separate 1
Obstruction within device 1
Cut in material 1
Device damaged prior to use 1
Failure to deliver 1
Sticking 1
Slippage of device or device component 1
Failure to read input signal 1
Total Device Problems 1222

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

-
-