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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 1
ALLUMIN8, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 7
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
CMF MEDICON SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
EFFORTMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 2
G SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GREENS SURGICALS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HC BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HIGHRIDGE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET
  SUBSTANTIALLY EQUIVALENT 2
INGENIUM SPINE
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
LOCK-IN USA CORP
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 6
MEDOS-INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDYNUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEASIA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  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.H.PITKAR ORTHOTOOLS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
S.M.A.I.O
  SUBSTANTIALLY EQUIVALENT 6
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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 ALIGNMENT SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL RESOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEWAY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TESLAKE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
XTANT MEDICAL HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1745 1752
2022 1339 1348
2023 919 939
2024 1614 1617
2025 1190 1190

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1275 1284
Break 944 958
Migration 880 887
Fracture 768 774
Material Deformation 485 485
Loosening of Implant Not Related to Bone-Ingrowth 414 415
Material Twisted/Bent 383 384
Device Slipped 276 276
Device Dislodged or Dislocated 259 261
Detachment of Device or Device Component 210 210
Insufficient Information 203 203
Device-Device Incompatibility 164 165
Mechanical Problem 116 117
Material Fragmentation 78 78
Material Separation 78 78
Malposition of Device 71 71
Mechanics Altered 62 62
Use of Device Problem 59 60
Improper or Incorrect Procedure or Method 56 56
Compatibility Problem 54 54
Appropriate Term/Code Not Available 46 47
Entrapment of Device 45 47
Material Integrity Problem 45 46
Patient Device Interaction Problem 42 43
Migration or Expulsion of Device 39 39
No Apparent Adverse Event 36 36
Loose or Intermittent Connection 33 33
Premature Separation 26 26
Separation Problem 25 25
Mechanical Jam 19 19
Inaccurate Information 18 18
Separation Failure 18 18
Unintended Movement 18 18
Noise, Audible 15 16
Expulsion 12 12
Patient-Device Incompatibility 11 11
Biocompatibility 11 11
Product Quality Problem 10 10
Wrong Label 10 10
Device Damaged by Another Device 9 9
Failure to Osseointegrate 9 9
Contamination /Decontamination Problem 9 9
Physical Resistance/Sticking 9 9
Crack 9 9
Difficult to Advance 9 9
Osseointegration Problem 8 8
Device Handling Problem 8 8
Backflow 7 7
Off-Label Use 7 7
Difficult to Remove 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3071 3082
Insufficient Information 869 871
Pain 731 733
Unspecified Infection 485 488
Failure of Implant 449 455
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 344 345
Osteolysis 211 216
Non-union Bone Fracture 156 161
Foreign Body In Patient 110 115
Nerve Damage 101 101
Joint Laxity 84 84
Spinal Cord Injury 83 83
Bone Fracture(s) 82 83
Post Operative Wound Infection 78 79
Unspecified Tissue Injury 70 73
Deformity/ Disfigurement 69 72
Necrosis 59 59
Numbness 58 58
Device Embedded In Tissue or Plaque 50 50
Inadequate Osseointegration 48 48
Vertebral Fracture 44 45
Hematoma 43 46
Hypersensitivity/Allergic reaction 41 41
Unspecified Nervous System Problem 40 43
Swelling/ Edema 35 35
Spinal Column Injury 33 33
Impaired Healing 33 33
Ambulation Difficulties 27 27
No Consequences Or Impact To Patient 27 27
Intervertebral Disc Compression or Protrusion 27 27
Discomfort 26 26
Pressure Sores 26 26
Stenosis 25 25
Implant Pain 24 24
Cerebrospinal Fluid Leakage 24 27
Paresthesia 22 22
Hemorrhage/Bleeding 22 22
Inflammation 21 21
Physical Asymmetry 21 21
Muscle Weakness 20 21
Paralysis 16 16
Fall 15 15
Cardiac Arrest 13 13
Neuropathy 12 12
Unspecified Musculoskeletal problem 11 11
Fatigue 11 11
Skin Tears 10 10
Urinary Incontinence 10 10
Movement Disorder 10 10
Unspecified Mental, Emotional or Behavioural Problem 10 10

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 Icotec Ag II Dec-19-2022
4 Integrity Implants Inc. II Dec-05-2022
5 Integrity Implants Inc. II Dec-05-2022
6 Orthofix U.S. LLC II Nov-07-2025
7 SAFE ORTHOPAEDICS LLC II Aug-24-2022
8 SEASPINE ORTHOPEDICS CORPORATION II Dec-23-2024
9 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
10 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
11 SPINEART SA II Aug-08-2025
12 SPINEART SA II May-03-2024
13 SPINEART SA II Jun-28-2021
14 XTANT Medical Holdings, Inc II Oct-17-2024
15 XTANT Medical Holdings, Inc II Jan-29-2024
16 Zimmer Biomet Spine Inc. II Jan-04-2024
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