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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
ALLIANCE PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTFX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS , LTD.
  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
ELITE SURGICAL SUPPLIES (PTY), LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, 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 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
INDIUS MEDICAL TECHNOLOGIES PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
KAHTNU SURGICAL, INC.
  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 4
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
NUTECH SPINE AND BIOLOGICS
  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
ORTHOPAEDIC & SPINE DEVELOPMENT
  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
PRISM SURGICAL DESIGN PTY , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL SIMPLICITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT
  SUBSTANTIALLY EQUIVALENT 1
SPINENET, LLC
  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 GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 400 402
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 461 462
Migration 409 411
Adverse Event Without Identified Device or Use Problem 369 389
Break 218 220
Material Integrity Problem 141 142
Detachment of Device or Device Component 90 90
Insufficient Device Problem Information 86 90
Device Dislodged or Dislocated 83 83
Mechanical Problem 72 72
Patient Device Interaction Problem 67 67
Compatibility Problem 52 52
Material Twisted/Bent 51 53
Material Deformation 49 50
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Material Fragmentation 42 42
Biocompatibility 33 33
Migration or Expulsion of Device 33 33
Device-Device Incompatibility 32 33
Patient-Device Incompatibility 30 33
Device Slipped 28 28
Device Appears to Trigger Rejection 24 24
Material Separation 21 21
Separation Problem 19 19
Wrong Label 18 18
Difficult to Insert 17 17
Use of Device Problem 17 17
No Apparent Adverse Event 15 15
Packaging Problem 13 13
Inflation Problem 13 13
Appropriate Device Problem Term/Code Not Available 12 12
Unstable 11 11
Mechanical Jam 10 10
Expulsion 9 9
Unintended Movement 9 9
Misassembly by Users 9 9
Device Damaged by Another Device 8 8
Human-Device Interface Problem 8 8
Off-Label Use 8 8
Improper or Incorrect Procedure or Method 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Activation, Positioning or Separation Problem 7 7
Mechanics Altered 7 7
Malposition of Device 7 7
Positioning Problem 7 7
Product Quality Problem 6 6
Inadequacy of Device Shape and/or Size 6 6
Failure to Osseointegrate 6 6
Entrapment of Device 5 5
Deformation Due to Compressive Stress 4 4
Unintended System Motion 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1063 1070
Insufficient Information 374 384
Failure of Implant 241 246
Pain 237 242
No Consequences Or Impact To Patient 103 103
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 92 93
Nonunion/Delayed-union Bone Fracture 65 66
Nerve Damage 62 64
Dysphagia/ Odynophagia 56 56
Unspecified Infection 55 56
Implant Pain 51 51
Unspecified Tissue Injury 50 50
Neck Pain 49 49
No Known Impact Or Consequence To Patient 49 49
No Code Available 49 49
Osteolysis 42 52
Injury 40 40
Hematoma 38 40
Numbness 31 34
Foreign Body In Patient 27 27
Bone Fracture(s) 25 25
Post Operative Wound Infection 21 21
Cerebrospinal Fluid Leakage 16 16
Discomfort 15 15
Physical Asymmetry 15 16
Spinal Column Injury 14 14
Device Embedded In Tissue or Plaque 13 13
Hypersensitivity/Allergic reaction 12 12
Inadequate Osseointegration 11 12
Patient Problem/Medical Problem 11 11
Spinal deformity 10 10
Hemorrhage/Blood Loss/Bleeding 10 10
Rash 9 9
Unspecified Nervous System Problem 9 9
Vertebral Fracture 9 9
Loss of Range of Motion 8 8
Hyporesponsive to stimuli 8 10
Swelling 8 8
Swelling/ Edema 7 7
Perforation of Vessels 7 7
Wound Dehiscence 7 7
Spinal Cord Injury 7 7
Speech Disorder 6 6
No Patient Involvement 6 6
Joint Laxity 6 7
Inflammation 6 6
Perforation of Esophagus 6 6
Stenosis 6 6
Fever 5 5
Subluxation 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Jun-07-2021
2 Clariance-SAS II Apr-15-2026
3 Innovasis, Inc II May-20-2020
4 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Mar-11-2021
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