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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 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 6
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED/71164
  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 1
BK MEDITECH, CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BLACK BOX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CALVARY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 7
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
COLIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GRAFTON MEDICAL ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 3
IMPLANET
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRITY IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 3
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
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
ORION BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
  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
RELIANCE MEDICAL SYSTEMS, LLC
  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 2
S.M.A.I.O.
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
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 3
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COPANY INDIA PRIVATE LIMITED
  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
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEWAY
  SUBSTANTIALLY EQUIVALENT 1
SPINEWAY SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEWELDING AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 2
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
WILTROM CORPORATION LIMITED
  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
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 1915 1915
2020 2076 2076
2021 1735 1737
2022 1340 1340
2023 920 920
2024 627 627

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1755 1755
Break 1278 1278
Migration 1057 1058
Fracture 966 966
Material Deformation 655 655
Loosening of Implant Not Related to Bone-Ingrowth 421 421
Detachment of Device or Device Component 344 344
Device Slipped 308 308
Material Twisted/Bent 290 290
Device-Device Incompatibility 230 230
Device Dislodged or Dislocated 210 211
Loose or Intermittent Connection 209 209
Insufficient Information 173 173
Unintended Movement 140 140
Mechanical Problem 133 133
Migration or Expulsion of Device 123 123
Appropriate Term/Code Not Available 110 110
Material Separation 108 108
Material Fragmentation 93 93
Material Split, Cut or Torn 72 72
Material Integrity Problem 70 70
Malposition of Device 65 65
No Apparent Adverse Event 60 60
Improper or Incorrect Procedure or Method 59 59
Patient Device Interaction Problem 56 56
Biocompatibility 47 47
Use of Device Problem 45 45
Mechanical Jam 42 42
Crack 37 37
Compatibility Problem 36 36
Entrapment of Device 32 32
Mechanics Altered 31 31
Separation Problem 28 28
Patient-Device Incompatibility 25 25
Premature Separation 24 24
Difficult to Remove 23 23
Failure to Align 18 18
Failure to Osseointegrate 17 17
Inaccurate Information 17 17
Noise, Audible 17 17
Separation Failure 16 16
Disconnection 15 15
Corroded 14 14
Expulsion 12 12
Physical Resistance/Sticking 12 12
Osseointegration Problem 11 11
Naturally Worn 9 9
Device Damaged by Another Device 9 9
Inadequacy of Device Shape and/or Size 9 9
Activation, Positioning or Separation Problem 8 8
Difficult to Insert 8 8
Positioning Problem 8 8
Device Handling Problem 7 7
Product Quality Problem 7 7
Positioning Failure 7 7
Difficult to Advance 7 7
Contamination /Decontamination Problem 7 7
Calibration Problem 6 6
Off-Label Use 6 6
Scratched Material 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Misassembled During Installation 5 5
Unintended System Motion 5 5
Peeled/Delaminated 5 5
Misassembled 4 4
Contamination 4 4
Deformation Due to Compressive Stress 4 4
Unstable 4 4
Failure to Disconnect 4 4
Defective Device 3 3
Device Markings/Labelling Problem 3 3
Leak/Splash 3 3
Nonstandard Device 3 3
Device Appears to Trigger Rejection 3 3
Material Rupture 3 3
Packaging Problem 3 3
Installation-Related Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Misassembly by Users 2 2
Output Problem 2 2
Material Protrusion/Extrusion 2 2
Material Frayed 2 2
Difficult to Fold, Unfold or Collapse 2 2
Human-Device Interface Problem 2 2
Connection Problem 2 2
Solder Joint Fracture 2 2
Residue After Decontamination 2 2
Fitting Problem 2 2
Microbial Contamination of Device 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Unexpected Therapeutic Results 1 1
Dull, Blunt 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Device Displays Incorrect Message 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Disintegration 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2220 2222
No Code Available 1140 1140
Pain 990 990
No Known Impact Or Consequence To Patient 858 858
Failure of Implant 780 781
Insufficient Information 511 511
No Consequences Or Impact To Patient 510 510
Unspecified Infection 509 509
Injury 465 465
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 294 294
Osteolysis 197 197
Non-union Bone Fracture 159 159
Nerve Damage 153 153
Foreign Body In Patient 124 124
Bone Fracture(s) 108 108
Hypersensitivity/Allergic reaction 90 90
Post Operative Wound Infection 85 85
No Information 84 84
Joint Laxity 83 83
Device Embedded In Tissue or Plaque 69 69
Spinal Cord Injury 59 59
Unspecified Tissue Injury 59 59
Patient Problem/Medical Problem 50 50
Inadequate Osseointegration 47 47
Hematoma 47 47
No Patient Involvement 45 45
Paralysis 43 43
Neurological Deficit/Dysfunction 42 42
Numbness 40 40
Spinal Column Injury 39 39
Impaired Healing 36 36
Vertebral Fracture 34 34
Unspecified Nervous System Problem 32 32
Discomfort 30 30
Swelling/ Edema 28 28
Limited Mobility Of The Implanted Joint 26 26
Tissue Damage 26 26
Death 25 25
Stenosis 25 25
Pressure Sores 23 23
Cerebrospinal Fluid Leakage 22 22
Fall 21 21
Not Applicable 21 21
Itching Sensation 19 19
Physical Asymmetry 18 18
Inflammation 17 17
Swelling 16 16
Dysphagia/ Odynophagia 16 16
Hemorrhage/Bleeding 15 15
Cardiac Arrest 14 14
Rash 14 14
Ambulation Difficulties 13 13
Deformity/ Disfigurement 13 13
Neuropathy 11 11
Fever 11 11
Intervertebral Disc Compression or Protrusion 11 11
Implant Pain 10 10
Foreign Body Reaction 10 10
Muscle Weakness 10 10
Skin Tears 10 10
Decreased Sensitivity 9 9
Pulmonary Embolism 9 9
Paraplegia 8 8
Thromboembolism 8 8
Paresthesia 8 8
Hypoesthesia 8 8
Ulcer 8 8
Malunion of Bone 8 8
Unspecified Musculoskeletal problem 7 7
Loss of Range of Motion 7 7
Weakness 7 7
Reaction 7 7
Blood Loss 7 7
Abscess 7 7
Fatigue 7 7
Purulent Discharge 7 7
Wound Dehiscence 6 6
Bacterial Infection 6 6
Paresis 6 6
Tissue Breakdown 6 6
Inadequate Pain Relief 6 6
Perforation of Vessels 6 6
Hernia 5 5
Neck Pain 5 5
Thrombosis 5 5
Metal Related Pathology 5 5
Pocket Erosion 4 4
Local Reaction 4 4
Internal Organ Perforation 4 4
Necrosis 4 4
Calcium Deposits/Calcification 4 4
Disability 4 4
Joint Disorder 4 4
Intraoperative Pain 4 4
Respiratory Failure 4 4
Embolism/Embolus 4 4
Thrombosis/Thrombus 4 4
Unspecified Vascular Problem 3 3
Constipation 3 3
Convulsion/Seizure 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 CTL Medical Corporation II Mar-20-2019
4 Clariance Inc III Jul-18-2019
5 Howmedica Osteonics Corp. II Aug-05-2019
6 Icotec Ag II Dec-19-2022
7 Integrity Implants Inc. II Dec-05-2022
8 Integrity Implants Inc. II Dec-05-2022
9 Medicrea International II Mar-02-2020
10 Medicrea International II Dec-30-2019
11 OrthoPediatrics Corp II Jul-30-2020
12 SAFE ORTHOPAEDICS LLC II Aug-24-2022
13 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
14 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
15 SPINEART SA II May-03-2024
16 SPINEART SA II Jun-28-2021
17 U&I CORP. II Jul-20-2020
18 XTANT Medical Holdings, Inc II Jan-29-2024
19 Zimmer Biomet Spine Inc. II Jan-04-2024
20 Zimmer Biomet Spine Inc. II Feb-22-2019
21 Zimmer Biomet, Inc. II Dec-15-2020
22 Zimmer Biomet, Inc. II Jun-02-2020
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