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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 SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 6
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
AXIS ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BK MEDITECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BK MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BK MEDITECH, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLACK BOX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
BLACK BOX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CALVARY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 6
CHIRAL SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE SAS
  SUBSTANTIALLY EQUIVALENT 1
CLEARVIEW ORTHOPEDIC DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
COLIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAFTON MEDICAL ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INGENIUM SPINE
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 3
KALITEC DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
LINKSPINE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA INTERNATIONAL S.A
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 4
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 4
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORBBO SURGICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ORION BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORTHOCIRCLE SPINE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PHAMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIA SPINE LTD.
  SUBSTANTIALLY EQUIVALENT 2
PRESIDIO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, L.L.C.
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
S. M. A. I. O
  SUBSTANTIALLY EQUIVALENT 1
S.M.A.I.O
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
SEOHANCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG KANGSHENG MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI REACH MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SANYOU MEDICAL CO, LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ANALYTICS & GEOMETRICAL IMPLANT CO, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL RESOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINE SMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINEART
  SUBSTANTIALLY EQUIVALENT 4
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 6
SPINEWAY SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEWELDING AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
VALORUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
WILTROM CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2017 1615 1615
2018 1681 1681
2019 1915 1915
2020 2066 2066
2021 1746 1748

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1810 1810
Adverse Event Without Identified Device or Use Problem 1215 1215
Fracture 980 980
Material Deformation 825 825
Migration 803 804
Loose or Intermittent Connection 521 521
Detachment of Device or Device Component 339 339
Migration or Expulsion of Device 328 328
Loosening of Implant Not Related to Bone-Ingrowth 288 288
Device Slipped 280 280
Unintended Movement 238 238
Device Operates Differently Than Expected 206 206
Device Dislodged or Dislocated 196 197
Device-Device Incompatibility 177 177
Material Twisted/Bent 177 177
Mechanical Problem 147 147
Appropriate Term/Code Not Available 119 119
Material Separation 110 110
Material Split, Cut or Torn 101 101
Disassembly 80 80
Material Fragmentation 74 74
Material Integrity Problem 73 73
Insufficient Information 72 72
Torn Material 60 60
No Apparent Adverse Event 49 49
Malposition of Device 48 48
Patient Device Interaction Problem 46 46
Mechanical Jam 44 44
Biocompatibility 44 44
Detachment Of Device Component 44 44
Failure to Align 43 43
Crack 40 40
Difficult to Remove 37 37
Calibration Problem 34 34
Compatibility Problem 30 30
Use of Device Problem 29 29
Disconnection 27 27
Entrapment of Device 22 22
Noise, Audible 22 22
Naturally Worn 21 21
Positioning Problem 20 20
Separation Problem 20 20
Patient-Device Incompatibility 20 20
Bent 19 19
Corroded 17 17
Improper or Incorrect Procedure or Method 16 16
Device Markings/Labelling Problem 15 15
Mechanics Altered 14 14
Difficult to Insert 13 13
Device Damaged by Another Device 12 12
Premature Separation 11 11
Metal Shedding Debris 11 11
Failure to Osseointegrate 11 11
Unstable 11 11
Inadequacy of Device Shape and/or Size 9 9
Separation Failure 8 8
Physical Resistance/Sticking 7 7
Connection Problem 6 6
Peeled/Delaminated 6 6
Product Quality Problem 5 5
Misassembled 5 5
Unintended System Motion 5 5
Failure To Adhere Or Bond 5 5
Failure to Disconnect 5 5
Material Protrusion/Extrusion 5 5
Installation-Related Problem 5 5
Osseointegration Problem 5 5
Device Handling Problem 5 5
Unstable Capture Threshold 5 5
Packaging Problem 5 5
Misassembled During Installation 4 4
Scratched Material 4 4
Device Operational Issue 4 4
Difficult to Advance 4 4
Expulsion 4 4
Contamination /Decontamination Problem 4 4
Nonstandard Device 4 4
Fitting Problem 4 4
Positioning Failure 3 3
Leak/Splash 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Protective Measures Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Deformation Due to Compressive Stress 2 2
Flaked 2 2
Material Frayed 2 2
Component Incompatible 2 2
Material Disintegration 2 2
Structural Problem 2 2
Solder Joint Fracture 2 2
Device Issue 2 2
Device Appears to Trigger Rejection 2 2
Difficult To Position 2 2
Off-Label Use 2 2
Material Rupture 2 2
Suction Problem 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1890 1890
No Code Available 1706 1706
No Clinical Signs, Symptoms or Conditions 1172 1174
Failure of Implant 1053 1054
Pain 1015 1015
Injury 798 798
No Consequences Or Impact To Patient 688 688
No Patient Involvement 273 273
No Information 273 273
Unspecified Infection 254 254
Spinal Column Injury 237 237
Not Applicable 196 196
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 183 183
Insufficient Information 142 142
Non-union Bone Fracture 133 133
Foreign Body In Patient 106 106
Bone Fracture(s) 97 97
Device Embedded In Tissue or Plaque 88 88
Nerve Damage 77 77
Hypersensitivity/Allergic reaction 75 75
Patient Problem/Medical Problem 59 59
Neurological Deficit/Dysfunction 54 54
Post Operative Wound Infection 48 48
Spinal Cord Injury 43 43
Fall 39 39
Death 38 38
Osteolysis 38 38
Numbness 36 36
Inadequate Osseointegration 35 35
Paralysis 35 35
Tissue Damage 34 34
Hematoma 32 32
Discomfort 32 32
Itching Sensation 28 28
Stenosis 27 27
Limited Mobility Of The Implanted Joint 27 27
Unspecified Tissue Injury 27 27
Reaction 19 19
Neuropathy 19 19
Blood Loss 17 17
Swelling 16 16
Rash 14 14
Ambulation Difficulties 14 14
Impaired Healing 13 13
Intraoperative Pain 12 12
Hemorrhage/Bleeding 12 12
Cardiac Arrest 12 12
Dysphagia/ Odynophagia 11 11
Fever 11 11
Vertebral Fracture 11 11
Weakness 10 10
Dizziness 9 9
Paraplegia 9 9
Ulcer 8 8
Pressure Sores 8 8
Hypoesthesia 8 8
Intervertebral Disc Compression or Protrusion 8 8
Paresis 8 8
Local Reaction 7 7
Abscess 7 7
Physical Asymmetry 7 7
Dyspnea 6 6
Tingling 6 6
Thrombosis 6 6
Inflammation 6 6
Loss of Range of Motion 6 6
Muscle Weakness 5 5
Arthritis 5 5
Fatigue 5 5
Cerebrospinal Fluid Leakage 5 5
Malunion of Bone 5 5
Disability 5 5
Neck Pain 5 5
Sudden Cardiac Death 4 4
Respiratory Failure 4 4
Joint Disorder 4 4
Implant Pain 4 4
Foreign Body Reaction 4 4
Calcium Deposits/Calcification 4 4
Internal Organ Perforation 4 4
Rupture 3 3
Hernia 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Wound Dehiscence 3 3
Unspecified Vascular Problem 3 3
Constipation 3 3
Depression 3 3
Collapse 3 3
Sedation 3 3
Perforation of Esophagus 2 2
Convulsion/Seizure 2 2
Cancer 2 2
Swelling/ Edema 2 2
Abdominal Pain 2 2
Damage to Ligament(s) 2 2
Muscle Spasm(s) 2 2
Extravasation 2 2
Skin Irritation 2 2
Perforation of Vessels 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Jun-06-2017
2 Amendia, Inc II Jan-10-2018
3 Back 2 Basics Direct LLC II Aug-21-2018
4 CTL Medical Corporation II Mar-20-2019
5 Clariance Inc III Jul-18-2019
6 Howmedica Osteonics Corp. II Aug-05-2019
7 Innovasis, Inc II Feb-20-2018
8 Medicrea International II Mar-02-2020
9 Medicrea International II Dec-30-2019
10 Medtronic Sofamor Danek USA Inc II Aug-03-2018
11 OrthoPediatrics Corp II Jul-30-2020
12 Orthofix, Inc II Aug-18-2017
13 SPINEART SA II Jun-28-2021
14 U&I CORP. II Jul-20-2020
15 Zimmer Biomet Spine Inc. II Feb-22-2019
16 Zimmer Biomet, Inc. II Dec-15-2020
17 Zimmer Biomet, Inc. II Jun-02-2020
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