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TPLC - Total Product Life Cycle

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Device orthopedic 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
  SUBSTANTIALLY EQUIVALENT 1
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 9
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP.
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 3
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CUREXO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  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 10
MAZOR ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 6
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  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 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC SOFAMOR DANEK, USA INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NAVIBOT INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NAVBIT PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
NAVISWISS AG
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVARAD CORPORATION
  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
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
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 2
POINT ROBOTICS MEDTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
PRACTICAL NAVIGATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PREMIA SPINE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
REMEX MEDICAL CORPORATION
  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 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL THEATER, INC.
  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 1699 1699
2022 1164 1170

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 1156 1156
Break 1106 1106
Mechanical Problem 1014 1014
Insufficient Information 702 702
Non Reproducible Results 437 437
Fracture 435 435
Use of Device Problem 416 416
Computer Software Problem 415 415
Detachment of Device or Device Component 350 350
Material Deformation 344 344
Unintended Application Program Shut Down 325 325
Imprecision 302 302
Application Program Problem: Parameter Calculation Error 295 295
Adverse Event Without Identified Device or Use Problem 284 284
Connection Problem 276 276
Output Problem 247 247
Material Twisted/Bent 166 166
Incorrect, Inadequate or Imprecise Resultor Readings 162 162
Physical Resistance/Sticking 153 153
Application Program Problem 147 147
Unintended Movement 130 130
Defective Component 128 128
Mechanical Jam 126 126
Device Operates Differently Than Expected 116 116
Solder Joint Fracture 110 110
Residue After Decontamination 105 105
Display or Visual Feedback Problem 103 103
Device Slipped 99 99
Overheating of Device 90 90
Mechanics Altered 83 83
Positioning Problem 79 79
Loose or Intermittent Connection 78 78
Positioning Failure 74 74
Disassembly 73 73
Failure to Calibrate 70 70
Device-Device Incompatibility 68 68
Failure to Recalibrate 62 62
Intermittent Communication Failure 60 60
Electrical /Electronic Property Problem 59 59
Appropriate Term/Code Not Available 57 57
Material Frayed 56 56
Circuit Failure 55 55
Image Display Error/Artifact 53 53
Noise, Audible 50 50
Device Sensing Problem 46 46
Application Program Freezes, Becomes Nonfunctional 42 42
Bent 40 40
Communication or Transmission Problem 38 38
Difficult to Insert 38 38
No Apparent Adverse Event 38 38
Device Displays Incorrect Message 35 35
Calibration Problem 34 34
Defective Device 32 32
Computer Operating System Problem 32 32
Crack 30 30
Malposition of Device 29 29
Failure to Power Up 29 29
Difficult to Remove 28 28
Inappropriate Tactile Prompt/Feedback 28 28
Improper or Incorrect Procedure or Method 28 28
Electrical Power Problem 27 27
Deformation Due to Compressive Stress 27 27
Complete Loss of Power 26 26
Premature Separation 26 26
Device Operational Issue 26 26
Contamination /Decontamination Problem 25 25
Incorrect Measurement 25 25
Material Fragmentation 24 24
Naturally Worn 23 23
Entrapment of Device 23 23
No Display/Image 22 22
Suction Problem 22 22
Contamination of Device Ingredient or Reagent 22 22
Intermittent Loss of Power 21 21
Difficult or Delayed Positioning 21 21
Device Dislodged or Dislocated 20 20
Unstable 20 20
Inadequacy of Device Shape and/or Size 18 18
Material Split, Cut or Torn 17 17
Image Orientation Incorrect 17 17
Retraction Problem 16 16
Electrical Shorting 16 16
Power Problem 16 16
Operating System Becomes Nonfunctional 16 16
Degraded 15 15
Fluid Leak 15 15
Sharp Edges 15 15
Battery Problem 14 14
Loss of Osseointegration 13 13
Contamination 13 13
Separation Failure 13 13
Migration or Expulsion of Device 12 12
Fitting Problem 12 12
Separation Problem 11 11
Device Difficult to Setup or Prepare 10 10
Unintended System Motion 10 10
Off-Label Use 10 10
Material Separation 10 10
Interrogation Problem 9 9
Nonstandard Device 9 9

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 3101 3107
No Patient Involvement 1341 1341
No Consequences Or Impact To Patient 941 941
Injury 326 326
Pain 128 128
Foreign Body In Patient 120 120
Insufficient Information 81 81
Bone Fracture(s) 79 79
No Code Available 67 67
Unspecified Tissue Injury 64 64
No Information 61 61
Tissue Damage 59 59
Unspecified Infection 50 50
Device Embedded In Tissue or Plaque 42 42
Discomfort 41 41
Failure of Implant 20 20
Iatrogenic Source 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Joint Laxity 18 18
Inadequate Osseointegration 17 17
Laceration(s) 16 16
Nerve Damage 16 16
Cerebrospinal Fluid Leakage 15 15
Not Applicable 15 15
Spinal Column Injury 14 14
Unspecified Nervous System Problem 12 12
Deformity/ Disfigurement 10 10
Hip Fracture 10 10
Muscle Weakness 10 10
Loss of Range of Motion 9 9
Fibrosis 8 8
Complaint, Ill-Defined 7 7
Hemorrhage/Bleeding 7 7
Post Operative Wound Infection 6 6
Ambulation Difficulties 6 6
Missing Value Reason 5 5
Joint Dislocation 5 5
Erosion 5 5
Wound Dehiscence 4 4
Fall 4 4
Damage to Ligament(s) 4 4
Seroma 4 4
Paresis 3 3
Swelling 3 3
Numbness 3 3
Neuropathy 3 3
Inflammation 3 3
Headache 3 3
Hematoma 3 3
Aspiration/Inhalation 3 3
Bacterial Infection 3 3
Muscle/Tendon Damage 3 3
Swelling/ Edema 3 3
Physical Asymmetry 2 2
Peripheral Nervous Injury 2 2
Osteopenia/ Osteoporosis 2 2
Tissue Breakdown 2 2
Blood Loss 2 2
Test Result 2 2
Burn(s) 2 2
Fever 2 2
Arthritis 2 2
Paralysis 2 2
Dizziness 2 2
Spinal Cord Injury 2 2
Scar Tissue 2 2
Perforation of Vessels 2 2
Weakness 1 1
Discharge 1 1
Shock 1 1
Urinary Retention 1 1
Perforation 1 1
Synovitis 1 1
Therapeutic Effects, Unexpected 1 1
Thrombosis 1 1
Thrombus 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1
Collapse 1 1
Irritability 1 1
Osteolysis 1 1
Non-union Bone Fracture 1 1
Joint Disorder 1 1
Hypoesthesia 1 1
Joint Swelling 1 1
Neurological Deficit/Dysfunction 1 1
Incontinence 1 1
Irritation 1 1
Infiltration into Tissue 1 1
Chest Pain 1 1
Cyst(s) 1 1
Deposits 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Abscess 1 1
Achalasia 1 1
Patient Problem/Medical Problem 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 DePuy Orthopaedics, Inc. II May-02-2022
7 Exactech, Inc. II Jan-18-2018
8 Intellijoint Surgical, Inc. II Mar-23-2020
9 Intellijoint Surgical, Inc. II Aug-08-2019
10 K2M, Inc II Oct-07-2019
11 Mako Surgical Corporation II Sep-09-2022
12 Mako Surgical Corporation II Nov-19-2020
13 Mako Surgical Corporation II Jul-31-2020
14 Mako Surgical Corporation II Jun-16-2019
15 Mako Surgical Corporation II Sep-15-2018
16 Mako Surgical Corporation II Aug-24-2018
17 Mako Surgical Corporation II Aug-14-2018
18 Mako Surgical Corporation II May-04-2018
19 Mako Surgical Corporation II Sep-13-2017
20 Mako Surgical Corporation II Jul-18-2017
21 Mako Surgical Corporation II Mar-07-2017
22 Mako Surgical Corporation II Feb-11-2017
23 Mazor Robotics Ltd II Dec-20-2019
24 Medtronic Navigation, Inc. II Jun-09-2020
25 Medtronic Navigation, Inc. II Apr-10-2020
26 Medtronic Navigation, Inc. II Dec-19-2019
27 Medtronic Navigation, Inc. II Sep-21-2017
28 OMNIlife science Inc. II Jun-04-2019
29 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
30 Orthosoft, Inc. dba Zimmer CAS II Apr-26-2017
31 Orthosoft, Inc. dba Zimmer CAS II Apr-19-2017
32 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
33 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
34 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
35 Smith & Nephew, Inc. II Apr-01-2020
36 Think Surgical, Inc. II Aug-06-2018
37 Zimmer Biomet, Inc. II Feb-16-2018
38 Zimmer Biomet, Inc. II Nov-28-2017
39 Zimmer Biomet, Inc. II Mar-27-2017
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