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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
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 6
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 1
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 1
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
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 2
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 2
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
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 1
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS-INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 4
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
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 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 1
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 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 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 ELEMENTS, 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 1
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 2
ZIMMER BIOMET SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1681 1681
2019 1915 1915
2020 2066 2066
2021 1749 1751
2022 1347 1347

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1548 1548
Adverse Event Without Identified Device or Use Problem 1397 1397
Fracture 1011 1011
Migration 952 953
Material Deformation 772 772
Loose or Intermittent Connection 392 392
Loosening of Implant Not Related to Bone-Ingrowth 379 379
Detachment of Device or Device Component 351 351
Device Slipped 307 307
Material Twisted/Bent 245 245
Migration or Expulsion of Device 213 213
Device-Device Incompatibility 212 212
Device Dislodged or Dislocated 205 206
Unintended Movement 169 169
Mechanical Problem 140 140
Appropriate Term/Code Not Available 104 104
Material Separation 102 102
Material Split, Cut or Torn 101 101
Insufficient Information 82 82
Material Fragmentation 80 80
Device Operates Differently Than Expected 79 79
Material Integrity Problem 62 62
No Apparent Adverse Event 58 58
Patient Device Interaction Problem 53 53
Malposition of Device 52 52
Mechanical Jam 46 46
Biocompatibility 44 44
Crack 42 42
Calibration Problem 34 34
Use of Device Problem 32 32
Torn Material 32 32
Disassembly 30 30
Patient-Device Incompatibility 29 29
Failure to Align 28 28
Mechanics Altered 28 28
Compatibility Problem 27 27
Difficult to Remove 27 27
Disconnection 26 26
Entrapment of Device 25 25
Separation Problem 24 24
Premature Separation 20 20
Noise, Audible 18 18
Improper or Incorrect Procedure or Method 18 18
Detachment Of Device Component 16 16
Corroded 14 14
Positioning Problem 13 13
Osseointegration Problem 11 11
Failure to Osseointegrate 11 11
Bent 10 10
Difficult to Insert 10 10
Naturally Worn 10 10
Expulsion 10 10
Physical Resistance/Sticking 9 9
Inadequacy of Device Shape and/or Size 9 9
Separation Failure 8 8
Device Damaged by Another Device 8 8
Device Markings/Labelling Problem 6 6
Scratched Material 6 6
Metal Shedding Debris 6 6
Peeled/Delaminated 6 6
Product Quality Problem 5 5
Unintended System Motion 5 5
Positioning Failure 5 5
Unstable 5 5
Contamination /Decontamination Problem 5 5
Difficult to Advance 5 5
Installation-Related Problem 5 5
Misassembled During Installation 5 5
Device Handling Problem 5 5
Unstable Capture Threshold 5 5
Packaging Problem 4 4
Fitting Problem 4 4
Nonstandard Device 4 4
Misassembled 4 4
Device Appears to Trigger Rejection 3 3
Leak/Splash 3 3
Material Rupture 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Failure to Disconnect 3 3
Device Operational Issue 3 3
Deformation Due to Compressive Stress 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 2 2
Protective Measures Problem 2 2
Output Problem 2 2
Off-Label Use 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Structural Problem 2 2
Solder Joint Fracture 2 2
Difficult to Fold, Unfold or Collapse 2 2
Material Frayed 2 2
Component Incompatible 2 2
Flaked 2 2
Material Disintegration 2 2
Decoupling 1 1
Difficult or Delayed Positioning 1 1
Fluid/Blood Leak 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1710 1712
No Code Available 1423 1423
No Known Impact Or Consequence To Patient 1404 1404
Pain 987 987
Failure of Implant 826 827
No Consequences Or Impact To Patient 654 654
Injury 560 560
Unspecified Infection 456 456
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 277 277
Insufficient Information 222 222
Spinal Column Injury 218 218
Not Applicable 182 182
No Patient Involvement 157 157
No Information 153 153
Foreign Body In Patient 120 120
Non-union Bone Fracture 95 95
Bone Fracture(s) 94 94
Nerve Damage 87 87
Device Embedded In Tissue or Plaque 77 77
Hypersensitivity/Allergic reaction 76 76
Post Operative Wound Infection 67 67
Patient Problem/Medical Problem 57 57
Osteolysis 52 52
Neurological Deficit/Dysfunction 46 46
Spinal Cord Injury 45 45
Hematoma 42 42
Unspecified Tissue Injury 39 39
Inadequate Osseointegration 38 38
Paralysis 37 37
Numbness 35 35
Tissue Damage 33 33
Death 30 30
Itching Sensation 29 29
Discomfort 29 29
Limited Mobility Of The Implanted Joint 26 26
Stenosis 25 25
Fall 25 25
Vertebral Fracture 20 20
Cerebrospinal Fluid Leakage 16 16
Swelling 16 16
Hemorrhage/Bleeding 15 15
Reaction 15 15
Ambulation Difficulties 14 14
Rash 14 14
Neuropathy 13 13
Dysphagia/ Odynophagia 13 13
Physical Asymmetry 13 13
Blood Loss 12 12
Unspecified Nervous System Problem 11 11
Impaired Healing 11 11
Cardiac Arrest 11 11
Fever 10 10
Intervertebral Disc Compression or Protrusion 10 10
Skin Tears 10 10
Dizziness 9 9
Inflammation 9 9
Paresis 8 8
Weakness 8 8
Ulcer 8 8
Hypoesthesia 8 8
Intraoperative Pain 8 8
Joint Laxity 7 7
Malunion of Bone 7 7
Decreased Sensitivity 7 7
Local Reaction 7 7
Bacterial Infection 7 7
Purulent Discharge 7 7
Implant Pain 7 7
Fatigue 6 6
Dyspnea 6 6
Muscle Weakness 6 6
Tissue Breakdown 6 6
Loss of Range of Motion 6 6
Neck Pain 6 6
Paraplegia 5 5
Disability 5 5
Perforation of Vessels 5 5
Thrombosis 5 5
Wound Dehiscence 5 5
Abscess 5 5
Unspecified Musculoskeletal problem 5 5
Paresthesia 5 5
Swelling/ Edema 4 4
Arthritis 4 4
Calcium Deposits/Calcification 4 4
Foreign Body Reaction 4 4
Pocket Erosion 4 4
Internal Organ Perforation 4 4
Tingling 4 4
Pressure Sores 4 4
Joint Disorder 4 4
Respiratory Failure 4 4
Embolism/Embolus 4 4
Unspecified Vascular Problem 3 3
Metal Related Pathology 3 3
Osteomyelitis 3 3
Constipation 3 3
Convulsion/Seizure 3 3
Sudden Cardiac Death 3 3
Rupture 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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