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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
7D SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AUGMEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 4
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 5
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CUREXO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 6
INSIGHT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 1
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
KICO KNEE INNOVATION COMPANY PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
MAZOR ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 6
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC SOFAMOR DANEK, USA INC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NAVBIT PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
NAVISWISS AG
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
OMNLLIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN, INC.
  SUBSTANTIALLY EQUIVALENT 5
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOKEY ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT D/B/A ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 2
ORTOMA AB
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIXEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRACTICAL NAVIGATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIA SPINE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINAL ELEMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1075 1075
2018 1233 1233
2019 1585 1585
2020 2744 2744
2021 1694 1694

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 1119 1119
Break 1006 1006
Mechanical Problem 1001 1001
Insufficient Information 693 693
Non Reproducible Results 437 437
Computer Software Problem 411 411
Detachment of Device or Device Component 341 341
Material Deformation 334 334
Use of Device Problem 333 333
Fracture 263 263
Adverse Event Without Identified Device or Use Problem 249 249
Output Problem 241 241
Imprecision 240 240
Application Program Problem: Parameter Calculation Error 239 239
Unintended Application Program Shut Down 232 232
Connection Problem 194 194
Material Twisted/Bent 148 148
Application Program Problem 146 146
Defective Component 128 128
Incorrect, Inadequate or Imprecise Resultor Readings 121 121
Device Operates Differently Than Expected 116 116
Mechanical Jam 114 114
Solder Joint Fracture 101 101
Physical Resistance/Sticking 95 95
Unintended Movement 94 94
Display or Visual Feedback Problem 91 91
Overheating of Device 80 80
Loose or Intermittent Connection 75 75
Disassembly 73 73
Positioning Failure 67 67
Failure to Recalibrate 62 62
Residue After Decontamination 61 61
Failure to Calibrate 60 60
Electrical /Electronic Property Problem 57 57
Material Frayed 56 56
Image Display Error/Artifact 53 53
Mechanics Altered 50 50
Appropriate Term/Code Not Available 50 50
Intermittent Communication Failure 50 50
Circuit Failure 48 48
Device-Device Incompatibility 43 43
Bent 40 40
Communication or Transmission Problem 37 37
Noise, Audible 36 36
Positioning Problem 36 36
Device Displays Incorrect Message 35 35
Device Sensing Problem 34 34
Difficult to Insert 33 33
Defective Device 32 32
Calibration Problem 32 32
Crack 30 30
No Apparent Adverse Event 30 30
Device Slipped 29 29
Difficult to Remove 28 28
Failure to Power Up 28 28
Malposition of Device 27 27
Deformation Due to Compressive Stress 27 27
Electrical Power Problem 27 27
Inappropriate Tactile Prompt/Feedback 26 26
Device Operational Issue 26 26
Incorrect Measurement 23 23
Contamination of Device Ingredient or Reagent 22 22
Suction Problem 22 22
Complete Loss of Power 22 22
Computer Operating System Problem 21 21
No Display/Image 21 21
Difficult or Delayed Positioning 20 20
Contamination /Decontamination Problem 20 20
Application Program Freezes, Becomes Nonfunctional 20 20
Naturally Worn 20 20
Premature Separation 19 19
Device Dislodged or Dislocated 19 19
Inadequacy of Device Shape and/or Size 18 18
Unstable 17 17
Image Orientation Incorrect 17 17
Material Fragmentation 17 17
Entrapment of Device 16 16
Electrical Shorting 16 16
Power Problem 16 16
Operating System Becomes Nonfunctional 16 16
Sharp Edges 15 15
Improper or Incorrect Procedure or Method 15 15
Fluid Leak 14 14
Degraded 13 13
Contamination 13 13
Separation Failure 13 13
Battery Problem 13 13
Loss of Osseointegration 13 13
Material Split, Cut or Torn 13 13
Fitting Problem 12 12
Migration or Expulsion of Device 12 12
Device Difficult to Setup or Prepare 10 10
Off-Label Use 10 10
Retraction Problem 10 10
Material Separation 10 10
Separation Problem 10 10
Migration 8 8
Intermittent Loss of Power 8 8
Interrogation Problem 8 8
Misassembly by Users 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3483 3483
No Clinical Signs, Symptoms or Conditions 2026 2026
No Patient Involvement 1341 1341
No Consequences Or Impact To Patient 941 941
Injury 326 326
Pain 124 124
Foreign Body In Patient 103 103
Bone Fracture(s) 70 70
No Code Available 67 67
Insufficient Information 62 62
No Information 61 61
Tissue Damage 59 59
Unspecified Infection 44 44
Discomfort 40 40
Device Embedded In Tissue or Plaque 38 38
Unspecified Tissue Injury 24 24
Iatrogenic Source 18 18
Inadequate Osseointegration 17 17
Failure of Implant 17 17
Not Applicable 15 15
Joint Laxity 14 14
Spinal Column Injury 14 14
Nerve Damage 10 10
Hip Fracture 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Unspecified Nervous System Problem 9 9
Cerebrospinal Fluid Leakage 8 8
Complaint, Ill-Defined 7 7
Fibrosis 7 7
Ambulation Difficulties 6 6
Deformity/ Disfigurement 6 6
Laceration(s) 6 6
Loss of Range of Motion 6 6
Hemorrhage/Bleeding 5 5
Joint Dislocation 5 5
Missing Value Reason 5 5
Wound Dehiscence 4 4
Damage to Ligament(s) 4 4
Muscle Weakness 4 4
Inflammation 3 3
Swelling 3 3
Headache 3 3
Aspiration/Inhalation 3 3
Bacterial Infection 3 3
Post Operative Wound Infection 3 3
Swelling/ Edema 3 3
Muscle/Tendon Damage 2 2
Dizziness 2 2
Spinal Cord Injury 2 2
Blood Loss 2 2
Test Result 2 2
Perforation of Vessels 2 2
Paralysis 2 2
Erosion 2 2
Burn(s) 2 2
Arthritis 2 2
Fall 2 2
Fever 2 2
Scar Tissue 2 2
Seroma 2 2
Shock 1 1
Synovitis 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Thrombus 1 1
Irritation 1 1
Incontinence 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Abscess 1 1
Achalasia 1 1
Hematoma 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Chest Pain 1 1
Cyst(s) 1 1
Deposits 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Paresis 1 1
Weakness 1 1
Discharge 1 1
Osteolysis 1 1
Numbness 1 1
Collapse 1 1
Irritability 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Joint Swelling 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
Sleep Dysfunction 1 1
Paraplegia 1 1
Injection Site Reaction 1 1
Physical Asymmetry 1 1
Movement Disorder 1 1
Peripheral Nervous Injury 1 1
Embolism/Embolus 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 Mazor Robotics Ltd II Dec-20-2019
22 Medtronic Navigation, Inc. II Jun-09-2020
23 Medtronic Navigation, Inc. II Apr-10-2020
24 Medtronic Navigation, Inc. II Dec-19-2019
25 Medtronic Navigation, Inc. II Sep-21-2017
26 OMNIlife science Inc. II Jun-04-2019
27 Orthosoft, Inc. dba Zimmer CAS II Apr-26-2017
28 Orthosoft, Inc. dba Zimmer CAS II Apr-19-2017
29 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
30 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
31 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
32 Smith & Nephew, Inc. II Apr-01-2020
33 Think Surgical, Inc. II Aug-06-2018
34 Zimmer Biomet, Inc. II Feb-16-2018
35 Zimmer Biomet, Inc. II Nov-28-2017
36 Zimmer Biomet, Inc. II Mar-27-2017
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