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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 4
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD
  SUBSTANTIALLY EQUIVALENT 1
AUGMEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 2
BLUE BELT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 8
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 5
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 10
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 6
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CUREXO, INC.
  SUBSTANTIALLY EQUIVALENT 3
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 2
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 1
FUSION ROBOTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU LANCET ROBOTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  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, INC.
  SUBSTANTIALLY EQUIVALENT 2
KALITEC DIRECT, LLC DOING BUSINESS AS KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC SOFAMOR DANEK, USA INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT NAVIBOT INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NAVBIT PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
NAVISWISS AG
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVARAD CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
ONPOINT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN INC
  SUBSTANTIALLY EQUIVALENT 1
ORTHALIGN, 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 5
ORTHOSOFT INC (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 3
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PATHKEEPER SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIXEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
POINT ROBOTICS MEDTECH INC.
  SUBSTANTIALLY EQUIVALENT 2
POLARISAR INC.
  SUBSTANTIALLY EQUIVALENT 1
PRACTICAL NAVIGATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
PREMIA SPINE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROPRIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
REMEX MEDICAL CORP.
  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 2
SPINAL ELEMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL THEATER, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THINK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1585 1585
2020 2744 2744
2021 1696 1696
2022 1568 1576
2023 1490 1490
2024 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1002 1002
Material Integrity Problem 840 840
Mechanical Problem 704 704
Use of Device Problem 601 601
Unintended Application Program Shut Down 435 435
Fracture 431 431
Application Program Problem: Parameter Calculation Error 391 391
Device Slipped 353 353
Connection Problem 336 336
Computer Software Problem 318 318
Imprecision 314 314
Incorrect, Inadequate or Imprecise Result or Readings 295 295
Detachment of Device or Device Component 268 268
Insufficient Information 255 255
Non Reproducible Results 235 235
Adverse Event Without Identified Device or Use Problem 229 229
Physical Resistance/Sticking 194 194
Unintended Movement 191 191
Material Twisted/Bent 175 175
Mechanical Jam 169 169
Application Program Problem 149 149
Residue After Decontamination 148 148
Output Problem 144 144
Device-Device Incompatibility 141 141
Defective Component 126 126
Malposition of Device 121 121
Display or Visual Feedback Problem 112 112
Positioning Problem 111 111
Solder Joint Fracture 110 110
Failure to Calibrate 100 100
Overheating of Device 94 94
Mechanics Altered 92 92
Positioning Failure 86 86
Intermittent Continuity 72 72
Intermittent Communication Failure 68 68
Appropriate Term/Code Not Available 66 66
Loose or Intermittent Connection 63 63
Failure to Recalibrate 62 62
Noise, Audible 62 62
Material Fragmentation 59 59
Device Sensing Problem 59 59
Circuit Failure 58 58
Application Program Freezes, Becomes Nonfunctional 58 58
Material Frayed 57 57
Material Deformation 57 57
Improper or Incorrect Procedure or Method 52 52
Premature Separation 49 49
Image Display Error/Artifact 43 43
Difficult to Insert 41 41
Computer Operating System Problem 40 40
No Apparent Adverse Event 40 40
Incorrect Measurement 36 36
Intermittent Loss of Power 34 34
Contamination /Decontamination Problem 33 33
Unstable 31 31
Defective Device 31 31
Inappropriate Tactile Prompt/Feedback 31 31
Complete Loss of Power 30 30
Crack 30 30
Entrapment of Device 29 29
Failure to Power Up 28 28
No Visual Prompts/Feedback 28 28
Retraction Problem 26 26
Calibration Problem 25 25
Contamination of Device Ingredient or Reagent 25 25
Deformation Due to Compressive Stress 24 24
Difficult to Remove 24 24
Leak/Splash 22 22
Electrical /Electronic Property Problem 22 22
Difficult or Delayed Positioning 22 22
Suction Problem 22 22
Vibration 21 21
No Display/Image 21 21
Material Split, Cut or Torn 20 20
Naturally Worn 19 19
Device Dislodged or Dislocated 18 18
Inadequacy of Device Shape and/or Size 18 18
Communication or Transmission Problem 17 17
Electrical Shorting 16 16
Component Missing 16 16
Unintended System Motion 16 16
Sharp Edges 16 16
Fluid/Blood Leak 15 15
Erratic or Intermittent Display 15 15
Battery Problem 15 15
Separation Failure 14 14
Electrical Power Problem 14 14
Power Problem 14 14
Operating System Becomes Nonfunctional 14 14
Loss of Osseointegration 13 13
Image Orientation Incorrect 13 13
Degraded 12 12
Off-Label Use 11 11
Fitting Problem 11 11
Separation Problem 11 11
Human-Device Interface Problem 10 10
Corroded 10 10
Nonstandard Device 9 9
Failure to Align 9 9
Interrogation Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4867 4875
No Known Impact Or Consequence To Patient 2068 2068
No Patient Involvement 901 901
No Consequences Or Impact To Patient 634 634
Injury 300 300
Unspecified Tissue Injury 170 170
Foreign Body In Patient 128 128
Insufficient Information 117 117
Pain 99 99
Bone Fracture(s) 67 67
Unspecified Infection 51 51
No Code Available 40 40
Device Embedded In Tissue or Plaque 37 37
Tissue Damage 36 36
Laceration(s) 32 32
Nerve Damage 28 28
No Information 28 28
Joint Laxity 24 24
Failure of Implant 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Unspecified Nervous System Problem 20 20
Muscle Weakness 19 19
Cerebrospinal Fluid Leakage 18 18
Inadequate Osseointegration 17 17
Discomfort 15 15
Hemorrhage/Bleeding 14 14
Deformity/ Disfigurement 11 11
Loss of Range of Motion 11 11
Post Operative Wound Infection 10 10
Hip Fracture 10 10
Ambulation Difficulties 10 10
Spinal Column Injury 9 9
Numbness 8 8
Fibrosis 8 8
Spinal Cord Injury 6 6
Complaint, Ill-Defined 6 6
Perforation 6 6
Wound Dehiscence 6 6
Erosion 5 5
Fall 5 5
Damage to Ligament(s) 5 5
Neuropathy 5 5
Paralysis 5 5
Joint Dislocation 5 5
Iatrogenic Source 5 5
Missing Value Reason 5 5
Swelling/ Edema 4 4
Rupture 4 4
Paresis 4 4
Seroma 4 4
Headache 4 4
Hematoma 3 3
Aspiration/Inhalation 3 3
Bacterial Infection 3 3
Urinary Retention 3 3
Scar Tissue 3 3
Muscle/Tendon Damage 3 3
Not Applicable 3 3
Tissue Breakdown 3 3
Fluid Discharge 3 3
Blood Loss 2 2
Test Result 2 2
Osteopenia/ Osteoporosis 2 2
Peripheral Nervous Injury 2 2
Vertebral Fracture 2 2
Physical Asymmetry 2 2
Swelling 2 2
Dizziness 2 2
Osteolysis 2 2
Fever 2 2
Cyst(s) 2 2
Inflammation 2 2
Neurological Deficit/Dysfunction 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Intracranial Hemorrhage 1 1
Incontinence 1 1
Infiltration into Tissue 1 1
Deposits 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Erythema 1 1
Chest Pain 1 1
Abscess 1 1
Achalasia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Impaired Healing 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Collapse 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1
Discharge 1 1
Urinary Frequency 1 1
Hypoesthesia 1 1
Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Nov-08-2022
2 Blue Belt Technologies, Inc II Jan-11-2024
3 Blue Belt Technologies, Inc II Oct-05-2023
4 Blue Ortho II Oct-23-2020
5 Blue Ortho II Feb-11-2020
6 Brainlab AG II Mar-28-2023
7 Brainlab AG II Aug-29-2020
8 Brainlab AG II Aug-13-2020
9 DePuy Orthopaedics, Inc. II May-02-2022
10 Exactech, Inc. II Jun-30-2023
11 Globus Medical, Inc. II Feb-07-2024
12 Globus Medical, Inc. I Jan-18-2024
13 Intellijoint Surgical, Inc. II Mar-23-2020
14 Intellijoint Surgical, Inc. II Aug-08-2019
15 K2M, Inc II Oct-07-2019
16 Mako Surgical Corporation II Sep-09-2022
17 Mako Surgical Corporation II Nov-19-2020
18 Mako Surgical Corporation II Jul-31-2020
19 Mako Surgical Corporation II Jun-16-2019
20 Mazor Robotics Ltd II Oct-12-2023
21 Mazor Robotics Ltd II Dec-20-2019
22 Medacta Usa Inc II Dec-03-2022
23 Medtronic Navigation, Inc. II Jan-10-2024
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 Sofamor Danek USA, Inc II Aug-09-2023
28 NuVasive Inc III Feb-03-2023
29 OMNIlife science Inc. II Jun-04-2019
30 Orthosoft, Inc. dba Zimmer CAS II Mar-03-2022
31 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Nov-02-2020
32 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-31-2020
33 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-27-2020
34 Smith & Nephew, Inc. II Apr-01-2020
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