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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
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 5
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
CORIN
  SUBSTANTIALLY EQUIVALENT 1
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CRYPTYCH PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 6
INTELLIJOINT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 3
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
MAZOR ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 6
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 9
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
ORTHALIGN, INC
  SUBSTANTIALLY EQUIVALENT 6
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 18
STRYKER CORPORATE
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 749 749
2017 1075 1075
2018 1233 1233
2019 1585 1585
2020 2743 2743
2021 431 431

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 1132 1132
Mechanical Problem 1118 1118
Break 1035 1035
Insufficient Information 697 697
Material Deformation 500 500
Computer Software Problem 449 449
Non Reproducible Results 433 433
Detachment of Device or Device Component 367 367
Use of Device Problem 287 287
Adverse Event Without Identified Device or Use Problem 271 271
Fracture 241 241
Output Problem 233 233
Device Operates Differently Than Expected 183 183
Imprecision 160 160
Application Program Problem 144 144
Application Program Problem: Parameter Calculation Error 138 138
Connection Problem 130 130
Defective Component 127 127
Material Twisted/Bent 126 126
Unintended Application Program Shut Down 119 119
Mechanical Jam 90 90
Disassembly 90 90
Unintended Movement 83 83
Incorrect, Inadequate or Imprecise Resultor Readings 78 78
Electrical /Electronic Property Problem 76 76
Display or Visual Feedback Problem 75 75
Loose or Intermittent Connection 70 70
Bent 67 67
Failure to Recalibrate 62 62
Positioning Failure 59 59
Material Frayed 57 57
Solder Joint Fracture 55 55
Device Displays Incorrect Message 51 51
Image Display Error/Artifact 50 50
Overheating of Device 50 50
Failure to Calibrate 48 48
Physical Resistance/Sticking 46 46
Communication or Transmission Problem 44 44
Calibration Problem 30 30
Crack 30 30
Positioning Problem 29 29
Intermittent Communication Failure 28 28
Difficult to Remove 28 28
Device Operational Issue 27 27
Device Damaged by Another Device 27 27
Device Sensing Problem 27 27
Electrical Power Problem 27 27
Vibration 26 26
Noise, Audible 26 26
Mechanics Altered 25 25
Inappropriate Tactile Prompt/Feedback 24 24
Deformation Due to Compressive Stress 24 24
Failure to Power Up 24 24
Appropriate Term/Code Not Available 23 23
Malposition of Device 23 23
Contamination of Device Ingredient or Reagent 22 22
Difficult to Insert 22 22
Circuit Failure 22 22
Defective Device 22 22
Suction Problem 22 22
Residue After Decontamination 21 21
Device Inoperable 20 20
Device-Device Incompatibility 20 20
Device Slipped 20 20
Device Dislodged or Dislocated 20 20
Contamination /Decontamination Problem 19 19
Inadequacy of Device Shape and/or Size 19 19
Difficult or Delayed Positioning 18 18
Premature Separation 18 18
Complete Loss of Power 18 18
Migration or Expulsion of Device 18 18
Incorrect Measurement 17 17
Naturally Worn 17 17
Detachment Of Device Component 17 17
Image Orientation Incorrect 17 17
Electrical Shorting 16 16
Power Problem 16 16
Operating System Becomes Nonfunctional 16 16
No Apparent Adverse Event 16 16
Material Fragmentation 15 15
No Display/Image 15 15
Sharp Edges 15 15
Device Contamination with Chemical or Other Material 15 15
Contamination 15 15
Improper or Incorrect Procedure or Method 14 14
Fluid Leak 14 14
Temperature Problem 14 14
Degraded 13 13
Unstable 12 12
Application Interface Becomes Non-Functional Or Program Exits Abnormally 12 12
Loss of Osseointegration 11 11
Separation Failure 11 11
Material Separation 11 11
Smoking 10 10
Computer Operating System Problem 10 10
Battery Problem 10 10
Fitting Problem 9 9
Device Difficult to Setup or Prepare 9 9
Off-Label Use 9 9
Material Split, Cut or Torn 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3894 3894
No Patient Involvement 1432 1432
No Consequences Or Impact To Patient 1130 1130
No Clinical Signs, Symptoms or Conditions 739 739
Injury 334 334
Pain 121 121
Foreign Body In Patient 106 106
Tissue Damage 86 86
No Information 79 79
Bone Fracture(s) 72 72
No Code Available 71 71
Discomfort 49 49
Device Embedded In Tissue or Plaque 42 42
Unspecified Infection 39 39
Iatrogenic Source 36 36
Insufficient Information 31 31
Spinal Column Injury 30 30
Inadequate Osseointegration 15 15
Not Applicable 15 15
Hip Fracture 9 9
Failure of Implant 8 8
Unspecified Tissue Injury 7 7
Complaint, Ill-Defined 7 7
Nerve Damage 6 6
Joint Dislocation 6 6
Ambulation Difficulties 5 5
Missing Value Reason 5 5
Joint Laxity 4 4
Fibrosis 4 4
Damage to Ligament(s) 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Loss of Range of Motion 4 4
Muscle Weakness 3 3
Inflammation 3 3
Wound Dehiscence 3 3
Aspiration/Inhalation 3 3
Swelling 3 3
Bacterial Infection 3 3
Headache 3 3
Joint Disorder 3 3
Post Operative Wound Infection 3 3
Dizziness 2 2
Scar Tissue 2 2
Seroma 2 2
Blood Loss 2 2
Test Result 2 2
Spinal Cord Injury 2 2
Cerebrospinal Fluid Leakage 2 2
Fall 2 2
Arthritis 2 2
Perforation of Vessels 2 2
Fluid Discharge 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Fever 1 1
Hematoma 1 1
Irritation 1 1
Cyst(s) 1 1
Deposits 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Burn(s) 1 1
Abscess 1 1
Sleep Dysfunction 1 1
Discharge 1 1
Peripheral Nervous Injury 1 1
Embolism/Embolus 1 1
Muscle/Tendon Damage 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Thrombus 1 1
Osteolysis 1 1
Numbness 1 1
Collapse 1 1
Radiation Exposure, Unintended 1 1
Patient Problem/Medical Problem 1 1
Injection Site Reaction 1 1
Swelling/ Edema 1 1
Unspecified Nervous System Problem 1 1
Shock 1 1
Synovitis 1 1
Paralysis 1 1
Hemorrhage/Bleeding 1 1
Incontinence 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Laceration(s) 1 1
Therapeutic Response, Decreased 1 1
Weakness 1 1
Joint Swelling 1 1
Paraplegia 1 1
Reaction 1 1
Irritability 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Blue Ortho II Oct-23-2020
2 Blue Ortho II Feb-11-2020
3 Brainlab AG II Aug-29-2020
4 Brainlab AG II Aug-13-2020
5 Brainlab AG II Oct-11-2018
6 Exactech, Inc. II Jan-18-2018
7 Intellijoint Surgical, Inc. II Mar-23-2020
8 Intellijoint Surgical, Inc. II Aug-08-2019
9 K2M, Inc II Oct-07-2019
10 Mako Surgical Corporation II Nov-19-2020
11 Mako Surgical Corporation II Jul-31-2020
12 Mako Surgical Corporation II Jun-16-2019
13 Mako Surgical Corporation II Sep-15-2018
14 Mako Surgical Corporation II Aug-24-2018
15 Mako Surgical Corporation II Aug-14-2018
16 Mako Surgical Corporation II May-04-2018
17 Mako Surgical Corporation II Sep-13-2017
18 Mako Surgical Corporation II Jul-18-2017
19 Mako Surgical Corporation II Mar-07-2017
20 Mako Surgical Corporation II Feb-11-2017
21 Mako Surgical Corporation II Apr-29-2016
22 Mako Surgical Corporation II Apr-28-2016
23 Mako Surgical Corporation II Apr-18-2016
24 Mazor Robotics Ltd II Dec-20-2019
25 Medtronic Navigation, Inc. II Jun-09-2020
26 Medtronic Navigation, Inc. II Apr-10-2020
27 Medtronic Navigation, Inc. II Dec-19-2019
28 Medtronic Navigation, Inc. II Sep-21-2017
29 Medtronic Navigation, Inc. II Aug-02-2016
30 OMNI LIFE SCIENCE III Nov-17-2016
31 OMNIlife science Inc. II Jun-04-2019
32 Orthosoft, Inc. dba Zimmer CAS II Apr-26-2017
33 Orthosoft, Inc. dba Zimmer CAS II Apr-19-2017
34 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
35 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
36 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
37 Smith & Nephew, Inc. II Apr-01-2020
38 Think Surgical, Inc. II Aug-06-2018
39 Zimmer Biomet, Inc. II Feb-16-2018
40 Zimmer Biomet, Inc. II Nov-28-2017
41 Zimmer Biomet, Inc. II Mar-27-2017
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