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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, spinal intervertebral body
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeKWQ
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 2
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTFX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BETHESDA MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
EFFORTMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 2
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HUVEXEL CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES INC. (KMTI)
  SUBSTANTIALLY EQUIVALENT 2
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYNUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE
  SUBSTANTIALLY EQUIVALENT 1
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
OAK TREE ENGINEERING, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX US, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT
  SUBSTANTIALLY EQUIVALENT 1
SPINEUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 591 606
2022 392 401
2023 320 324
2024 419 421
2025 251 251
2026 193 193

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 363 364
Migration 353 355
Adverse Event Without Identified Device or Use Problem 312 332
Break 146 148
Material Integrity Problem 132 133
Insufficient Device Problem Information 84 88
Device Dislodged or Dislocated 82 82
Detachment of Device or Device Component 82 82
Patient Device Interaction Problem 63 63
Mechanical Problem 61 61
Compatibility Problem 47 47
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Material Deformation 42 43
Material Twisted/Bent 41 43
Material Fragmentation 39 39
Patient-Device Incompatibility 29 32
Biocompatibility 27 27
Device-Device Incompatibility 26 27
Device Slipped 24 24
Device Appears to Trigger Rejection 24 24
Separation Problem 19 19
Material Separation 19 19
Wrong Label 18 18
Difficult to Insert 17 17
Use of Device Problem 17 17
Migration or Expulsion of Device 17 17
Inflation Problem 13 13
Packaging Problem 13 13
No Apparent Adverse Event 12 12
Unstable 11 11
Appropriate Device Problem Term/Code Not Available 10 10
Misassembly by Users 9 9
Device Damaged by Another Device 8 8
Off-Label Use 8 8
Human-Device Interface Problem 8 8
Mechanical Jam 8 8
Unintended Movement 7 7
Malposition of Device 7 7
Mechanics Altered 7 7
Improper or Incorrect Procedure or Method 6 6
Activation, Positioning or Separation Problem 6 6
Product Quality Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Inadequacy of Device Shape and/or Size 5 5
Positioning Problem 5 5
Entrapment of Device 4 4
Failure to Osseointegrate 4 4
Material Discolored 3 3
Osseointegration Problem 3 3
Unintended System Motion 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 980 987
Insufficient Information 366 376
Failure of Implant 219 224
Pain 198 201
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 92 93
Nonunion/Delayed-union Bone Fracture 65 66
Nerve Damage 62 64
Implant Pain 51 51
Unspecified Tissue Injury 50 50
Unspecified Infection 49 50
Osteolysis 41 51
Dysphagia/ Odynophagia 40 40
Neck Pain 32 32
Hematoma 28 30
Numbness 25 26
Foreign Body In Patient 23 23
Bone Fracture(s) 21 21
Post Operative Wound Infection 20 20
Cerebrospinal Fluid Leakage 16 16
No Code Available 15 15
Physical Asymmetry 15 16
Spinal Column Injury 14 14
Discomfort 12 12
Inadequate Osseointegration 11 12
Device Embedded In Tissue or Plaque 11 11
Spinal deformity 10 10
Hemorrhage/Blood Loss/Bleeding 9 9
Vertebral Fracture 9 9
Unspecified Nervous System Problem 9 9
Loss of Range of Motion 8 8
Hyporesponsive to stimuli 7 9
Perforation of Vessels 7 7
Swelling/ Edema 7 7
Spinal Cord Injury 7 7
Wound Dehiscence 7 7
Speech Disorder 6 6
Joint Laxity 6 7
Muscle Weakness/Atrophy 5 5
Fever 5 5
Subluxation 5 5
Hypersensitivity/Allergic reaction 5 5
Inflammation 5 5
Fluid Discharge 4 4
Burning Sensation 4 4
Muscular Rigidity 4 4
Dysphasia 4 4
Neck Stiffness 4 4
Stenosis 4 4
Dural Tear 4 4
Laceration(s) of Esophagus 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Jun-07-2021
2 Clariance-SAS II Apr-15-2026
3 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Mar-11-2021
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