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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 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
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 2
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ROBOTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 5
HANGZHOU LANCET ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSIGHT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIJOINT SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
KICO KNEE INNOVATION COMPANY PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
MAZOR ROBOTICS LTD.
  SUBSTANTIALLY EQUIVALENT 4
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 4
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 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 3
ORTHALIGN INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOKEY ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT D/B/A ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 3
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 2
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
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
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
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
2018 1233 1233
2019 1585 1585
2020 2744 2744
2021 1699 1699
2022 1570 1578

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1070 1070
Material Integrity Problem 1053 1053
Mechanical Problem 764 764
Non Reproducible Results 435 435
Fracture 432 432
Use of Device Problem 431 431
Insufficient Information 415 415
Computer Software Problem 402 402
Unintended Application Program Shut Down 367 367
Detachment of Device or Device Component 319 319
Application Program Problem: Parameter Calculation Error 315 315
Connection Problem 296 296
Imprecision 281 281
Adverse Event Without Identified Device or Use Problem 229 229
Output Problem 211 211
Material Deformation 200 200
Incorrect, Inadequate or Imprecise Result or Readings 178 178
Physical Resistance/Sticking 169 169
Material Twisted/Bent 168 168
Application Program Problem 147 147
Unintended Movement 138 138
Device Slipped 135 135
Defective Component 127 127
Mechanical Jam 127 127
Residue After Decontamination 112 112
Solder Joint Fracture 110 110
Display or Visual Feedback Problem 106 106
Overheating of Device 89 89
Positioning Problem 86 86
Mechanics Altered 85 85
Device-Device Incompatibility 85 85
Failure to Calibrate 78 78
Positioning Failure 74 74
Intermittent Communication Failure 66 66
Failure to Recalibrate 62 62
Loose or Intermittent Connection 60 60
Appropriate Term/Code Not Available 59 59
Circuit Failure 58 58
Malposition of Device 57 57
Material Frayed 56 56
Noise, Audible 53 53
Image Display Error/Artifact 51 51
Device Sensing Problem 48 48
Application Program Freezes, Becomes Nonfunctional 46 46
Electrical /Electronic Property Problem 40 40
Difficult to Insert 38 38
No Apparent Adverse Event 36 36
Computer Operating System Problem 34 34
Defective Device 32 32
Incorrect Measurement 32 32
Premature Separation 31 31
Failure to Power Up 30 30
Crack 30 30
Calibration Problem 30 30
Inappropriate Tactile Prompt/Feedback 29 29
Device Operates Differently Than Expected 28 28
Improper or Incorrect Procedure or Method 28 28
Material Fragmentation 28 28
Difficult to Remove 27 27
Electrical Power Problem 27 27
Deformation Due to Compressive Stress 26 26
Complete Loss of Power 26 26
Contamination /Decontamination Problem 25 25
Contamination of Device Ingredient or Reagent 25 25
Entrapment of Device 25 25
Intermittent Loss of Power 24 24
No Display/Image 23 23
Communication or Transmission Problem 23 23
Naturally Worn 22 22
Suction Problem 22 22
Unstable 22 22
Difficult or Delayed Positioning 22 22
Device Dislodged or Dislocated 20 20
Material Split, Cut or Torn 20 20
Retraction Problem 19 19
Inadequacy of Device Shape and/or Size 18 18
Image Orientation Incorrect 17 17
Bent 16 16
Power Problem 16 16
Operating System Becomes Nonfunctional 16 16
Sharp Edges 15 15
No Visual Prompts/Feedback 15 15
Degraded 15 15
Fluid/Blood Leak 15 15
Electrical Shorting 15 15
Battery Problem 14 14
Separation Failure 13 13
Loss of Osseointegration 13 13
Fitting Problem 12 12
Failure to Align 12 12
Contamination 12 12
Off-Label Use 11 11
Separation Problem 11 11
Unintended System Motion 10 10
Erratic or Intermittent Display 10 10
Device Displays Incorrect Message 10 10
Corroded 9 9
Nonstandard Device 9 9
Device Difficult to Setup or Prepare 9 9
Material Separation 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3450 3458
No Known Impact Or Consequence To Patient 2901 2901
No Patient Involvement 1147 1147
No Consequences Or Impact To Patient 720 720
Injury 317 317
Foreign Body In Patient 119 119
Pain 106 106
Unspecified Tissue Injury 94 94
Insufficient Information 92 92
Bone Fracture(s) 70 70
Tissue Damage 48 48
Unspecified Infection 48 48
No Information 43 43
No Code Available 42 42
Device Embedded In Tissue or Plaque 35 35
Failure of Implant 21 21
Laceration(s) 20 20
Discomfort 19 19
Joint Laxity 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Nerve Damage 18 18
Inadequate Osseointegration 17 17
Cerebrospinal Fluid Leakage 17 17
Not Applicable 13 13
Unspecified Nervous System Problem 13 13
Muscle Weakness 11 11
Hip Fracture 10 10
Deformity/ Disfigurement 10 10
Spinal Column Injury 9 9
Hemorrhage/Bleeding 9 9
Loss of Range of Motion 9 9
Fibrosis 8 8
Iatrogenic Source 7 7
Complaint, Ill-Defined 7 7
Post Operative Wound Infection 7 7
Ambulation Difficulties 6 6
Joint Dislocation 5 5
Erosion 5 5
Damage to Ligament(s) 5 5
Missing Value Reason 5 5
Seroma 4 4
Swelling/ Edema 4 4
Fall 4 4
Paresis 4 4
Aspiration/Inhalation 3 3
Hematoma 3 3
Bacterial Infection 3 3
Numbness 3 3
Neuropathy 3 3
Wound Dehiscence 3 3
Muscle/Tendon Damage 3 3
Headache 3 3
Paralysis 2 2
Scar Tissue 2 2
Blood Loss 2 2
Dizziness 2 2
Tissue Breakdown 2 2
Test Result 2 2
Physical Asymmetry 2 2
Rupture 2 2
Peripheral Nervous Injury 2 2
Fever 2 2
Osteopenia/ Osteoporosis 2 2
Spinal Cord Injury 2 2
Swelling 2 2
Fluid Discharge 2 2
Embolism/Embolus 1 1
Thrombosis 1 1
Discharge 1 1
Hypoesthesia 1 1
Collapse 1 1
Skin Tears 1 1
Intracranial Hemorrhage 1 1
Inflammation 1 1
Neurological Deficit/Dysfunction 1 1
Burn(s) 1 1
Cyst(s) 1 1
Deposits 1 1
Dyspnea 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Urinary Retention 1 1
Non-union Bone Fracture 1 1
Shock 1 1
Movement Disorder 1 1
Patient Problem/Medical Problem 1 1
Injection Site Reaction 1 1
Lethargy 1 1
Abscess 1 1
Achalasia 1 1
Dysphagia/ Odynophagia 1 1
Erythema 1 1
Perforation 1 1
Infiltration into Tissue 1 1
Sleep Dysfunction 1 1
Therapeutic Effects, Unexpected 1 1
Thrombus 1 1
Perforation of Vessels 1 1
Tactile Disorders 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Nov-08-2022
2 Blue Ortho II Oct-23-2020
3 Blue Ortho II Feb-11-2020
4 Brainlab AG II Aug-29-2020
5 Brainlab AG II Aug-13-2020
6 Brainlab AG II Oct-11-2018
7 DePuy Orthopaedics, Inc. II May-02-2022
8 Exactech, Inc. II Jan-18-2018
9 Intellijoint Surgical, Inc. II Mar-23-2020
10 Intellijoint Surgical, Inc. II Aug-08-2019
11 K2M, Inc II Oct-07-2019
12 Mako Surgical Corporation II Sep-09-2022
13 Mako Surgical Corporation II Nov-19-2020
14 Mako Surgical Corporation II Jul-31-2020
15 Mako Surgical Corporation II Jun-16-2019
16 Mako Surgical Corporation II Sep-15-2018
17 Mako Surgical Corporation II Aug-24-2018
18 Mako Surgical Corporation II Aug-14-2018
19 Mako Surgical Corporation II May-04-2018
20 Mazor Robotics Ltd II Dec-20-2019
21 Medacta Usa Inc II Dec-03-2022
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 OMNIlife science Inc. II Jun-04-2019
26 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
27 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
28 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
29 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
30 Smith & Nephew, Inc. II Apr-01-2020
31 Think Surgical, Inc. II Aug-06-2018
32 Zimmer Biomet, Inc. II Feb-16-2018
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