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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
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 3
ALPHATEC SPINE, INC
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 4
AMEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AMENDIA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 3
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 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE SAS
  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 2
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FACETLINK DBA LINKSPINE
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
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 3
IMPLANET S.A.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 2
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 2
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
K2M, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
KALITEC DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
LINKSPINE INC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA INTERNATIONAL S.A
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 5
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 10
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 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
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 3
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSSO SURGICAL
  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 11
SENECKA SPINE
  SUBSTANTIALLY EQUIVALENT 1
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 2
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  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 BALANCE, INC.
  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 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 7
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEWAY S.A.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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
2016 1585 1585
2017 1615 1615
2018 1681 1681
2019 1915 1915
2020 2066 2066
2021 1362 1363

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2067 2067
Adverse Event Without Identified Device or Use Problem 1433 1433
Fracture 1105 1105
Material Deformation 800 800
Migration 771 771
Loose or Intermittent Connection 615 615
Migration or Expulsion of Device 442 442
Detachment of Device or Device Component 345 345
Device Slipped 307 307
Loosening of Implant Not Related to Bone-Ingrowth 275 275
Unintended Movement 270 270
Device Dislodged or Dislocated 266 267
Device Operates Differently Than Expected 224 224
Appropriate Term/Code Not Available 164 164
Device-Device Incompatibility 164 164
Material Twisted/Bent 160 160
Mechanical Problem 159 159
Torn Material 158 158
Material Separation 121 121
Insufficient Information 104 104
Disassembly 104 104
Material Fragmentation 100 100
Material Split, Cut or Torn 100 100
Failure to Align 86 86
Material Integrity Problem 81 81
Detachment Of Device Component 72 72
Malposition of Device 62 62
Difficult to Remove 57 57
No Apparent Adverse Event 51 51
Mechanical Jam 47 47
Biocompatibility 44 44
Patient Device Interaction Problem 43 43
Metal Shedding Debris 43 43
Crack 40 40
Use of Device Problem 36 36
Calibration Problem 34 34
Fitting Problem 33 33
Compatibility Problem 30 30
Device Damaged by Another Device 29 29
Disconnection 27 27
Positioning Problem 25 25
Bent 25 25
Difficult to Insert 24 24
Naturally Worn 22 22
Patient-Device Incompatibility 21 21
Noise, Audible 20 20
Device Markings/Labelling Problem 20 20
Entrapment of Device 19 19
Corroded 18 18
Separation Problem 18 18
Improper or Incorrect Procedure or Method 17 17
Device Inoperable 16 16
Failure To Adhere Or Bond 16 16
Mechanics Altered 12 12
Premature Separation 11 11
Failure to Osseointegrate 11 11
Unstable 10 10
Inadequacy of Device Shape and/or Size 9 9
Separation Failure 9 9
Device Issue 8 8
Peeled/Delaminated 7 7
Failure to Disconnect 7 7
Physical Resistance/Sticking 7 7
Connection Problem 7 7
Osseointegration Problem 5 5
Unstable Capture Threshold 5 5
Product Quality Problem 5 5
Misassembled 5 5
Nonstandard Device 5 5
Device Handling Problem 5 5
Installation-Related Problem 5 5
Material Protrusion/Extrusion 5 5
Packaging Problem 5 5
Device Operational Issue 5 5
Misassembled During Installation 4 4
Positioning Failure 4 4
Scratched Material 4 4
Dull, Blunt 4 4
Contamination /Decontamination Problem 4 4
Difficult to Advance 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Leak/Splash 3 3
Flaked 2 2
Material Frayed 2 2
Misconnection 2 2
Unintended System Motion 2 2
Device Appears to Trigger Rejection 2 2
Material Rupture 2 2
Solder Joint Fracture 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Distortion 2 2
Material Disintegration 2 2
Difficult To Position 2 2
Off-Label Use 2 2
Structural Problem 2 2
Deformation Due to Compressive Stress 2 2
Component Incompatible 2 2
Protective Measures Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2430 2430
No Code Available 2081 2081
Pain 1268 1268
Failure of Implant 1147 1148
Injury 1038 1038
No Clinical Signs, Symptoms or Conditions 926 927
No Consequences Or Impact To Patient 734 734
No Information 374 374
No Patient Involvement 278 278
Unspecified Infection 268 268
Spinal Column Injury 236 236
Not Applicable 200 200
Non-union Bone Fracture 157 157
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 152 152
Insufficient Information 126 126
Bone Fracture(s) 111 111
Foreign Body In Patient 109 109
Device Embedded In Tissue or Plaque 97 97
Nerve Damage 79 79
Hypersensitivity/Allergic reaction 77 77
Patient Problem/Medical Problem 62 62
Neurological Deficit/Dysfunction 58 58
Fall 54 54
Discomfort 52 52
Post Operative Wound Infection 51 51
Spinal Cord Injury 42 42
Death 41 41
Numbness 38 38
Inadequate Osseointegration 35 35
Reaction 35 35
Stenosis 34 34
Paralysis 34 34
Tissue Damage 34 34
Osteolysis 33 33
Impaired Healing 29 29
Itching Sensation 28 28
Limited Mobility Of The Implanted Joint 27 27
Unspecified Tissue Injury 24 24
Sedation 23 23
Neuropathy 23 23
Hematoma 22 22
Blood Loss 20 20
Swelling 17 17
Ambulation Difficulties 15 15
Rash 14 14
Dysphagia/ Odynophagia 13 13
Intraoperative Pain 13 13
Cardiac Arrest 12 12
Irritation 12 12
Fever 11 11
Weakness 11 11
Vertebral Fracture 11 11
Dizziness 9 9
Hemorrhage/Bleeding 9 9
Paraplegia 8 8
Abscess 8 8
Paresis 8 8
Intervertebral Disc Compression or Protrusion 8 8
Pressure Sores 8 8
Hypoesthesia 8 8
Physical Asymmetry 7 7
Ulcer 7 7
Cerebrospinal Fluid Leakage 7 7
Necrosis 7 7
Tingling 7 7
Local Reaction 7 7
Disability 6 6
Dyspnea 6 6
Inflammation 6 6
Loss of Range of Motion 6 6
Sudden Cardiac Death 6 6
Collapse 6 6
Thrombosis 6 6
Neck Pain 5 5
Fatigue 5 5
Arthritis 5 5
Internal Organ Perforation 5 5
Foreign Body Reaction 4 4
Bacterial Infection 4 4
Joint Disorder 4 4
Radiation Exposure, Unintended 4 4
Malunion of Bone 4 4
Wound Dehiscence 4 4
Calcium Deposits/Calcification 4 4
Muscle Weakness 4 4
Respiratory Failure 4 4
Unspecified Vascular Problem 3 3
Hernia 3 3
Muscle Spasm(s) 3 3
Autoimmune Reaction 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
Implant Pain 2 2
Swelling/ Edema 2 2

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 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
21 Zimmer Spine, Inc. II Mar-18-2016
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