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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 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 7
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 5
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 2
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 7
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
JMT 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 4
LINKSPINE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
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 2
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 3
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
NEXXT SPINE LLC
  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
OSTEOCENTRIC TECHNOLOGIES
  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
RIVARP MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
S. M. A. I. O
  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 10
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 2
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 2
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 5
SPINEART
  SUBSTANTIALLY EQUIVALENT 5
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
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES USA PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  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
VY SPINE, LLC
  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 1749 1751
2022 958 958

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1929 1929
Adverse Event Without Identified Device or Use Problem 1501 1501
Fracture 1093 1093
Migration 890 891
Material Deformation 877 877
Loose or Intermittent Connection 523 523
Detachment of Device or Device Component 371 371
Loosening of Implant Not Related to Bone-Ingrowth 357 357
Migration or Expulsion of Device 339 339
Device Slipped 315 315
Unintended Movement 240 240
Material Twisted/Bent 226 226
Device Dislodged or Dislocated 223 224
Device-Device Incompatibility 210 210
Device Operates Differently Than Expected 206 206
Mechanical Problem 161 161
Appropriate Term/Code Not Available 122 122
Material Separation 117 117
Material Split, Cut or Torn 101 101
Material Fragmentation 90 90
Insufficient Information 83 83
Material Integrity Problem 81 81
Disassembly 80 80
Malposition of Device 60 60
Torn Material 60 60
No Apparent Adverse Event 54 54
Patient Device Interaction Problem 51 51
Mechanical Jam 47 47
Biocompatibility 44 44
Detachment Of Device Component 44 44
Crack 43 43
Failure to Align 43 43
Difficult to Remove 38 38
Calibration Problem 34 34
Compatibility Problem 31 31
Use of Device Problem 30 30
Patient-Device Incompatibility 30 30
Disconnection 27 27
Mechanics Altered 27 27
Entrapment of Device 25 25
Noise, Audible 22 22
Separation Problem 22 22
Naturally Worn 21 21
Positioning Problem 20 20
Bent 19 19
Improper or Incorrect Procedure or Method 18 18
Corroded 17 17
Premature Separation 17 17
Device Markings/Labelling Problem 16 16
Difficult to Insert 14 14
Device Damaged by Another Device 12 12
Metal Shedding Debris 11 11
Failure to Osseointegrate 11 11
Unstable 11 11
Inadequacy of Device Shape and/or Size 9 9
Physical Resistance/Sticking 9 9
Expulsion 8 8
Separation Failure 8 8
Osseointegration Problem 7 7
Failure to Disconnect 6 6
Connection Problem 6 6
Device Handling Problem 6 6
Scratched Material 6 6
Peeled/Delaminated 6 6
Misassembled 6 6
Unintended System Motion 5 5
Failure To Adhere Or Bond 5 5
Product Quality Problem 5 5
Unstable Capture Threshold 5 5
Contamination /Decontamination Problem 5 5
Difficult to Advance 5 5
Material Protrusion/Extrusion 5 5
Packaging Problem 5 5
Installation-Related Problem 5 5
Device Operational Issue 4 4
Misassembled During Installation 4 4
Fitting Problem 4 4
Positioning Failure 4 4
Nonstandard Device 4 4
Leak/Splash 3 3
Therapeutic or Diagnostic Output Failure 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Protective Measures Problem 2 2
Output 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

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 1574 1576
Pain 1114 1114
Failure of Implant 1103 1104
Injury 798 798
No Consequences Or Impact To Patient 688 688
Unspecified Infection 457 457
No Information 273 273
No Patient Involvement 273 273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 270 270
Spinal Column Injury 245 245
Insufficient Information 198 198
Not Applicable 196 196
Non-union Bone Fracture 144 144
Foreign Body In Patient 128 128
Bone Fracture(s) 103 103
Device Embedded In Tissue or Plaque 95 95
Nerve Damage 82 82
Hypersensitivity/Allergic reaction 76 76
Post Operative Wound Infection 63 63
Patient Problem/Medical Problem 59 59
Neurological Deficit/Dysfunction 54 54
Osteolysis 49 49
Spinal Cord Injury 43 43
Fall 41 41
Hematoma 39 39
Death 38 38
Paralysis 38 38
Numbness 38 38
Inadequate Osseointegration 37 37
Tissue Damage 34 34
Discomfort 33 33
Stenosis 29 29
Itching Sensation 29 29
Unspecified Tissue Injury 29 29
Limited Mobility Of The Implanted Joint 27 27
Neuropathy 20 20
Reaction 19 19
Blood Loss 17 17
Swelling 16 16
Ambulation Difficulties 15 15
Impaired Healing 14 14
Rash 14 14
Vertebral Fracture 14 14
Dysphagia/ Odynophagia 13 13
Hemorrhage/Bleeding 13 13
Cardiac Arrest 12 12
Intraoperative Pain 12 12
Physical Asymmetry 12 12
Fever 11 11
Weakness 10 10
Paraplegia 9 9
Ulcer 9 9
Dizziness 9 9
Pressure Sores 8 8
Hypoesthesia 8 8
Paresis 8 8
Intervertebral Disc Compression or Protrusion 8 8
Inflammation 7 7
Muscle Weakness 7 7
Local Reaction 7 7
Purulent Discharge 7 7
Abscess 7 7
Malunion of Bone 7 7
Neck Pain 6 6
Tingling 6 6
Dyspnea 6 6
Loss of Range of Motion 6 6
Thrombosis 6 6
Implant Pain 6 6
Fatigue 5 5
Arthritis 5 5
Wound Dehiscence 5 5
Cerebrospinal Fluid Leakage 5 5
Disability 5 5
Unspecified Musculoskeletal problem 5 5
Paresthesia 5 5
Sudden Cardiac Death 4 4
Skin Tears 4 4
Joint Disorder 4 4
Respiratory Failure 4 4
Calcium Deposits/Calcification 4 4
Foreign Body Reaction 4 4
Pocket Erosion 4 4
Internal Organ Perforation 4 4
Swelling/ Edema 4 4
Myocardial Infarction 3 3
Autoimmune Reaction 3 3
Bacterial Infection 3 3
Collapse 3 3
Sedation 3 3
Perforation of Vessels 3 3
Rupture 3 3
Hernia 3 3
Depression 3 3
Unspecified Vascular Problem 3 3
Constipation 3 3
Convulsion/Seizure 3 3
Cancer 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Aug-26-2022
2 Aesculap Implant Systems LLC II Jul-21-2022
3 Alphatec Spine, Inc. II Jun-06-2017
4 Amendia, Inc II Jan-10-2018
5 Back 2 Basics Direct LLC II Aug-21-2018
6 CTL Medical Corporation II Mar-20-2019
7 Clariance Inc III Jul-18-2019
8 Howmedica Osteonics Corp. II Aug-05-2019
9 Innovasis, Inc II Feb-20-2018
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 Orthofix, Inc II Aug-18-2017
15 SAFE ORTHOPAEDICS LLC II Aug-24-2022
16 SPINEART SA II Jun-28-2021
17 U&I CORP. II Jul-20-2020
18 Zimmer Biomet Spine Inc. II Feb-22-2019
19 Zimmer Biomet, Inc. II Dec-15-2020
20 Zimmer Biomet, Inc. II Jun-02-2020
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