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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 7
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 5
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
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 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 7
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHIRAL SURGICAL
  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
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
GBS COMMONWEALTH CO., LTD.
  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
GRAFTON MEDICAL ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRITY IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JMT 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 2
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 10
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL
  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 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 4
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORION BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
PAONAN BIOTECH CO., LTD.
  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
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 2
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 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
SEOHANCARE 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 2
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
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 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 2
SPINEWAY SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEWELDING AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 2
VALORUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
WILTROM CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER BIOMET SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1684 1684
2019 1915 1915
2020 2066 2066
2021 1735 1737
2022 1340 1340
2023 527 527

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1610 1610
Adverse Event Without Identified Device or Use Problem 1452 1452
Fracture 1089 1089
Migration 1018 1019
Material Deformation 809 809
Loosening of Implant Not Related to Bone-Ingrowth 410 410
Loose or Intermittent Connection 392 392
Detachment of Device or Device Component 370 370
Device Slipped 316 316
Material Twisted/Bent 269 269
Device-Device Incompatibility 231 231
Device Dislodged or Dislocated 223 224
Migration or Expulsion of Device 218 218
Unintended Movement 171 171
Mechanical Problem 148 148
Appropriate Term/Code Not Available 121 121
Material Separation 111 111
Material Split, Cut or Torn 103 103
Material Fragmentation 91 91
Insufficient Information 84 84
Device Operates Differently Than Expected 79 79
Material Integrity Problem 71 71
Malposition of Device 61 61
No Apparent Adverse Event 59 59
Patient Device Interaction Problem 55 55
Biocompatibility 53 53
Mechanical Jam 46 46
Use of Device Problem 43 43
Crack 42 42
Compatibility Problem 39 39
Calibration Problem 34 34
Torn Material 32 32
Mechanics Altered 30 30
Disassembly 30 30
Entrapment of Device 30 30
Separation Problem 29 29
Difficult to Remove 28 28
Failure to Align 28 28
Patient-Device Incompatibility 26 26
Disconnection 26 26
Premature Separation 22 22
Improper or Incorrect Procedure or Method 21 21
Noise, Audible 18 18
Detachment Of Device Component 16 16
Separation Failure 15 15
Failure to Osseointegrate 15 15
Corroded 14 14
Positioning Problem 13 13
Physical Resistance/Sticking 12 12
Expulsion 11 11
Naturally Worn 10 10
Osseointegration Problem 10 10
Bent 10 10
Difficult to Insert 10 10
Inadequacy of Device Shape and/or Size 9 9
Device Damaged by Another Device 9 9
Activation, Positioning or Separation Problem 8 8
Device Markings/Labelling Problem 7 7
Device Handling Problem 7 7
Difficult to Advance 6 6
Scratched Material 6 6
Metal Shedding Debris 6 6
Positioning Failure 6 6
Peeled/Delaminated 6 6
Product Quality Problem 5 5
Unintended System Motion 5 5
Installation-Related Problem 5 5
Contamination /Decontamination Problem 5 5
Unstable Capture Threshold 5 5
Misassembled During Installation 5 5
Failure to Disconnect 4 4
Packaging Problem 4 4
Nonstandard Device 4 4
Misassembled 4 4
Fitting Problem 4 4
Unstable 4 4
Material Rupture 3 3
Deformation Due to Compressive Stress 3 3
Device Appears to Trigger Rejection 3 3
Leak/Splash 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Operational Issue 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Device Contaminated During Manufacture or Shipping 2 2
Connection Problem 2 2
Protective Measures Problem 2 2
Output Problem 2 2
Material Protrusion/Extrusion 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Frayed 2 2
Component Incompatible 2 2
Material Disintegration 2 2
Flaked 2 2
Structural Problem 2 2
Solder Joint Fracture 2 2
Residue After Decontamination 2 2
Off-Label Use 2 2
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1954 1956
No Code Available 1423 1423
No Known Impact Or Consequence To Patient 1404 1404
Pain 1062 1062
Failure of Implant 868 869
No Consequences Or Impact To Patient 654 654
Injury 560 560
Unspecified Infection 475 475
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
Insufficient Information 276 276
Spinal Column Injury 219 219
Not Applicable 182 182
No Patient Involvement 157 157
No Information 153 153
Foreign Body In Patient 134 134
Non-union Bone Fracture 101 101
Bone Fracture(s) 100 100
Nerve Damage 92 92
Device Embedded In Tissue or Plaque 85 85
Hypersensitivity/Allergic reaction 78 78
Post Operative Wound Infection 67 67
Osteolysis 59 59
Patient Problem/Medical Problem 57 57
Inadequate Osseointegration 46 46
Spinal Cord Injury 46 46
Hematoma 46 46
Neurological Deficit/Dysfunction 46 46
Unspecified Tissue Injury 44 44
Paralysis 41 41
Numbness 38 38
Tissue Damage 33 33
Discomfort 31 31
Death 30 30
Itching Sensation 29 29
Fall 27 27
Limited Mobility Of The Implanted Joint 26 26
Stenosis 25 25
Vertebral Fracture 20 20
Cerebrospinal Fluid Leakage 20 20
Unspecified Nervous System Problem 17 17
Swelling 16 16
Physical Asymmetry 16 16
Neuropathy 15 15
Inflammation 15 15
Ambulation Difficulties 15 15
Reaction 15 15
Rash 14 14
Dysphagia/ Odynophagia 14 14
Hemorrhage/Bleeding 13 13
Cardiac Arrest 13 13
Blood Loss 12 12
Impaired Healing 11 11
Fever 11 11
Intervertebral Disc Compression or Protrusion 11 11
Skin Tears 10 10
Dizziness 9 9
Weakness 8 8
Hypoesthesia 8 8
Deformity/ Disfigurement 8 8
Ulcer 8 8
Intraoperative Pain 8 8
Wound Dehiscence 8 8
Paresis 8 8
Malunion of Bone 8 8
Implant Pain 8 8
Joint Laxity 7 7
Muscle Weakness 7 7
Local Reaction 7 7
Abscess 7 7
Bacterial Infection 7 7
Fatigue 7 7
Purulent Discharge 7 7
Dyspnea 6 6
Loss of Range of Motion 6 6
Tissue Breakdown 6 6
Decreased Sensitivity 6 6
Unspecified Musculoskeletal problem 6 6
Paresthesia 6 6
Neck Pain 5 5
Thromboembolism 5 5
Disability 5 5
Paraplegia 5 5
Perforation of Vessels 5 5
Thrombosis 5 5
Pulmonary Embolism 5 5
Arthritis 4 4
Calcium Deposits/Calcification 4 4
Foreign Body Reaction 4 4
Internal Organ Perforation 4 4
Pocket Erosion 4 4
Respiratory Failure 4 4
Joint Disorder 4 4
Pressure Sores 4 4
Tingling 4 4
Embolism/Embolus 4 4
Thrombosis/Thrombus 4 4
Swelling/ Edema 4 4
Metal Related Pathology 4 4
Osteomyelitis 3 3
Unspecified Vascular Problem 3 3

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 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 Icotec Ag II Dec-19-2022
9 Innovasis, Inc II Feb-20-2018
10 Integrity Implants Inc. II Dec-05-2022
11 Integrity Implants Inc. II Dec-05-2022
12 Medicrea International II Mar-02-2020
13 Medicrea International II Dec-30-2019
14 Medtronic Sofamor Danek USA Inc II Aug-03-2018
15 OrthoPediatrics Corp II Jul-30-2020
16 SAFE ORTHOPAEDICS LLC II Aug-24-2022
17 SPINEART SA II Jun-28-2021
18 U&I CORP. II Jul-20-2020
19 Zimmer Biomet Spine Inc. II Feb-22-2019
20 Zimmer Biomet, Inc. II Dec-15-2020
21 Zimmer Biomet, Inc. II Jun-02-2020
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