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TPLC - Total Product Life Cycle

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Device thoracolumbosacral pedicle screw system
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Product CodeNKB
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 5
ALPHATEC HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 5
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BENVENUE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BK MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CALVARY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE
  SUBSTANTIALLY EQUIVALENT 2
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 6
CHOICE SPINE
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 4
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRAFTON MEDICAL ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 3
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTELLIGENT IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 3
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 5
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 10
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 13
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 4
NEO MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 6
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIA SPINE LTD.
  SUBSTANTIALLY EQUIVALENT 2
RTI SURGICAL, INC. (DBA RTI BIOLOGICS, INC.)
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
SHANGHAI SANYOU MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL BALANCE
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
SPINE SMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINEART
  SUBSTANTIALLY EQUIVALENT 4
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 8
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT MANUFACTURERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
WILTROM CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1585 1585
2017 1615 1615
2018 1680 1680
2019 1915 1915
2020 2066 2066
2021 551 553

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1967 1967
Adverse Event Without Identified Device or Use Problem 1283 1283
Fracture 1033 1033
Material Deformation 715 715
Migration 627 628
Loose or Intermittent Connection 604 604
Migration or Expulsion of Device 442 442
Detachment of Device or Device Component 312 312
Device Slipped 269 269
Unintended Movement 268 268
Device Dislodged or Dislocated 240 241
Loosening of Implant Not Related to Bone-Ingrowth 232 232
Device Operates Differently Than Expected 224 224
Appropriate Term/Code Not Available 161 161
Torn Material 158 158
Mechanical Problem 148 148
Device-Device Incompatibility 147 147
Material Twisted/Bent 128 128
Disassembly 104 104
Material Split, Cut or Torn 100 100
Material Separation 98 98
Insufficient Information 91 91
Material Fragmentation 89 89
Failure to Align 86 86
Material Integrity Problem 73 73
Detachment Of Device Component 72 72
Malposition of Device 59 59
Difficult to Remove 56 56
No Apparent Adverse Event 47 47
Biocompatibility 44 44
Metal Shedding Debris 43 43
Mechanical Jam 40 40
Crack 39 39
Calibration Problem 34 34
Use of Device Problem 33 33
Fitting Problem 33 33
Patient Device Interaction Problem 32 32
Compatibility Problem 27 27
Disconnection 26 26
Device Damaged by Another Device 25 25
Bent 25 25
Difficult to Insert 24 24
Positioning Problem 24 24
Naturally Worn 22 22
Patient-Device Incompatibility 20 20
Device Markings/Labelling Problem 20 20
Corroded 18 18
Improper or Incorrect Procedure or Method 17 17
Device Inoperable 16 16
Failure To Adhere Or Bond 16 16
Noise, Audible 16 16
Entrapment of Device 14 14
Failure to Osseointegrate 11 11
Unstable 10 10
Inadequacy of Device Shape and/or Size 9 9
Mechanics Altered 8 8
Device Issue 8 8
Separation Problem 8 8
Premature Separation 7 7
Peeled/Delaminated 7 7
Connection Problem 6 6
Failure to Disconnect 6 6
Physical Resistance/Sticking 6 6
Unstable Capture Threshold 5 5
Osseointegration Problem 5 5
Product Quality Problem 5 5
Misassembled 5 5
Device Handling Problem 5 5
Packaging Problem 5 5
Material Protrusion/Extrusion 5 5
Device Operational Issue 5 5
Separation Failure 5 5
Nonstandard Device 5 5
Positioning Failure 4 4
Difficult to Advance 4 4
Dull, Blunt 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Scratched Material 3 3
Leak/Splash 3 3
Installation-Related Problem 3 3
Protective Measures Problem 2 2
Misassembled During Installation 2 2
Material Disintegration 2 2
Difficult To Position 2 2
Off-Label Use 2 2
Deformation Due to Compressive Stress 2 2
Structural Problem 2 2
Component Incompatible 2 2
Flaked 2 2
Misconnection 2 2
Unintended System Motion 2 2
Material Rupture 2 2
Solder Joint Fracture 2 2
Material Distortion 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Moisture or Humidity Problem 1 1
Device Displays Incorrect Message 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2431 2431
No Code Available 2081 2081
Pain 1197 1197
Failure of Implant 1101 1102
Injury 1038 1038
No Consequences Or Impact To Patient 734 734
No Clinical Signs, Symptoms or Conditions 507 509
No Information 374 374
No Patient Involvement 278 278
Unspecified Infection 259 259
Spinal Column Injury 236 236
Not Applicable 200 200
Non-union Bone Fracture 147 147
Foreign Body In Patient 101 101
Bone Fracture(s) 101 101
Device Embedded In Tissue or Plaque 87 87
Hypersensitivity/Allergic reaction 75 75
Nerve Damage 70 70
Insufficient Information 64 64
Patient Problem/Medical Problem 62 62
Neurological Deficit/Dysfunction 58 58
Fall 54 54
Discomfort 50 50
Death 41 41
Spinal Cord Injury 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Reaction 35 35
Paralysis 34 34
Tissue Damage 34 34
Inadequate Osseointegration 30 30
Numbness 30 30
Itching Sensation 28 28
Limited Mobility Of The Implanted Joint 27 27
Impaired Healing 26 26
Stenosis 26 26
Post Operative Wound Infection 24 24
Sedation 23 23
Neuropathy 23 23
Blood Loss 20 20
Hematoma 17 17
Swelling 17 17
Rash 14 14
Dysphagia/ Odynophagia 13 13
Ambulation Difficulties 13 13
Intraoperative Pain 13 13
Unspecified Tissue Injury 13 13
Irritation 12 12
Weakness 11 11
Vertebral Fracture 10 10
Fever 10 10
Dizziness 9 9
Paraplegia 8 8
Paresis 8 8
Pressure Sores 8 8
Hypoesthesia 8 8
Osteolysis 7 7
Tingling 7 7
Local Reaction 7 7
Necrosis 7 7
Hemorrhage/Bleeding 6 6
Disability 6 6
Collapse 6 6
Thrombosis 6 6
Sudden Cardiac Death 6 6
Ulcer 6 6
Dyspnea 6 6
Arthritis 5 5
Cerebrospinal Fluid Leakage 5 5
Loss of Range of Motion 5 5
Internal Organ Perforation 5 5
Foreign Body Reaction 4 4
Bacterial Infection 4 4
Cardiac Arrest 4 4
Joint Disorder 4 4
Radiation Exposure, Unintended 4 4
Wound Dehiscence 4 4
Abscess 4 4
Calcium Deposits/Calcification 4 4
Respiratory Failure 4 4
Hernia 3 3
Autoimmune Reaction 3 3
Inflammation 3 3
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Constipation 3 3
Depression 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 2 2
Abdominal Pain 2 2
Infection, Pyrogenic 2 2
Scar Tissue 2 2
Complaint, Ill-Defined 2 2
Skin Irritation 2 2
Rupture 2 2
Neck Pain 2 2
Cancer 2 2
Unspecified Vascular Problem 2 2
Intervertebral Disc Compression or Protrusion 2 2
Sweating 1 1
Claudication 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Jun-06-2017
2 Alphatec Spine, Inc. II Nov-16-2016
3 Amendia, Inc II Jan-10-2018
4 Back 2 Basics Direct LLC II Aug-21-2018
5 CTL Medical Corporation II Mar-20-2019
6 Clariance Inc III Jul-18-2019
7 Howmedica Osteonics Corp. II Aug-05-2019
8 Innovasis, Inc II Feb-20-2018
9 Innovasis, Inc II Jan-19-2016
10 Medicrea International II Mar-02-2020
11 Medicrea International II Dec-30-2019
12 Medtronic Sofamor Danek USA Inc II Aug-03-2018
13 OrthoPediatrics Corp II Jul-30-2020
14 OrthoPediatrics Corp II Jan-08-2016
15 Orthofix, Inc II Aug-18-2017
16 U&I CORP. II Jul-20-2020
17 Zimmer Biomet Spine Inc. II Feb-22-2019
18 Zimmer Biomet, Inc. II Dec-15-2020
19 Zimmer Biomet, Inc. II Jun-02-2020
20 Zimmer Spine, Inc. II Mar-18-2016
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