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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
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
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

MDR Year MDR Reports MDR Events
2021 591 606
2022 392 401
2023 320 324
2024 419 421
2025 251 251
2026 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 340 341
Migration 337 339
Adverse Event Without Identified Device or Use Problem 289 309
Break 164 166
Material Integrity Problem 123 124
Device Dislodged or Dislocated 104 104
Insufficient Information 86 90
Detachment of Device or Device Component 85 85
Patient Device Interaction Problem 63 63
Mechanical Problem 61 61
Device Slipped 58 58
Compatibility Problem 47 47
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Material Deformation 41 42
Material Twisted/Bent 40 42
Material Fragmentation 39 39
Biocompatibility 27 27
Patient-Device Incompatibility 27 30
Device-Device Incompatibility 24 25
Device Appears to Trigger Rejection 24 24
Separation Problem 20 20
Material Separation 19 19
Migration or Expulsion of Device 18 18
Wrong Label 18 18
Difficult to Insert 17 17
Appropriate Term/Code Not Available 15 15
Use of Device Problem 14 14
Packaging Problem 13 13
Inflation Problem 13 13
No Apparent Adverse Event 12 12
Unstable 11 11
Loose or Intermittent Connection 10 10
Mechanics Altered 9 9
Misassembly by Users 9 9
Device Damaged by Another Device 8 8
Mechanical Jam 8 8
Off-Label Use 8 8
Human-Device Interface Problem 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Malposition of Device 7 7
Entrapment of Device 7 7
Activation, Positioning or Separation Problem 6 6
Defective Device 6 6
Product Quality Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Improper or Incorrect Procedure or Method 6 6
Positioning Problem 5 5
Failure to Osseointegrate 4 4
Unintended Movement 4 4
Material Discolored 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 937 944
Insufficient Information 344 354
Failure of Implant 212 217
Pain 185 188
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 89 90
Nerve Damage 60 62
Non-union Bone Fracture 51 52
Unspecified Tissue Injury 50 50
Implant Pain 49 49
Unspecified Infection 47 48
Osteolysis 39 49
Dysphagia/ Odynophagia 38 38
Neck Pain 29 29
Hematoma 26 28
Numbness 25 26
Foreign Body In Patient 22 22
Bone Fracture(s) 21 21
Post Operative Wound Infection 18 18
Physical Asymmetry 15 16
No Code Available 15 15
Cerebrospinal Fluid Leakage 13 13
Spinal Column Injury 13 13
Device Embedded In Tissue or Plaque 11 11
Inadequate Osseointegration 10 11
Vertebral Fracture 9 9
Hemorrhage/Bleeding 9 9
Discomfort 9 9
Unspecified Nervous System Problem 9 9
Spinal Cord Injury 7 7
Wound Dehiscence 7 7
Swelling/ Edema 7 7
Decreased Sensitivity 7 9
Perforation of Vessels 7 7
Joint Laxity 6 7
Loss of Range of Motion 6 6
Speech Disorder 6 6
Fever 5 5
Muscle Weakness 5 5
Inflammation 5 5
Hypersensitivity/Allergic reaction 5 5
Subluxation 5 5
Burning Sensation 4 4
Muscular Rigidity 4 4
Nicks, cuts or tears of dura or other tissues by device 4 4
Stenosis 4 4
Fluid Discharge 4 4
Neuropathy 3 3
Dysphasia 3 3
Crushing Injury 3 3
Laceration(s) of Esophagus 3 3

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