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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 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
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
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
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.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC. (KMTI)
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
NUTECH SPINE AND BIOLOGICS
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
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
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.,
  SUBSTANTIALLY EQUIVALENT 1
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 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINENET LLC
  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 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 400 400
2021 581 581
2022 395 396
2023 318 318
2024 417 417
2025 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 380 381
Migration 339 339
Adverse Event Without Identified Device or Use Problem 302 302
Break 212 212
Material Integrity Problem 113 113
Detachment of Device or Device Component 93 93
Device Dislodged or Dislocated 80 80
Insufficient Information 76 76
Device Slipped 62 62
Mechanical Problem 61 61
Patient Device Interaction Problem 49 49
Material Deformation 45 45
Compatibility Problem 44 44
Material Twisted/Bent 43 43
Loosening of Implant Not Related to Bone-Ingrowth 42 42
Biocompatibility 35 35
Migration or Expulsion of Device 32 32
Material Fragmentation 29 29
Patient-Device Incompatibility 28 28
Device-Device Incompatibility 25 25
Device Appears to Trigger Rejection 24 24
Appropriate Term/Code Not Available 19 19
Material Separation 19 19
No Apparent Adverse Event 15 15
Wrong Label 13 13
Difficult to Insert 13 13
Packaging Problem 13 13
Separation Problem 12 12
Inflation Problem 11 11
Unstable 11 11
Loose or Intermittent Connection 10 10
Expulsion 9 9
Use of Device Problem 9 9
Device Damaged by Another Device 9 9
Mechanics Altered 9 9
Improper or Incorrect Procedure or Method 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Misassembly by Users 8 8
Malposition of Device 8 8
Off-Label Use 8 8
Entrapment of Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Positioning Problem 7 7
Mechanical Jam 7 7
Activation, Positioning or Separation Problem 6 6
Human-Device Interface Problem 6 6
Material Protrusion/Extrusion 6 6
Failure to Osseointegrate 6 6
Product Quality Problem 5 5
Deformation Due to Compressive Stress 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 881 882
Insufficient Information 271 271
Pain 208 208
Failure of Implant 187 187
No Consequences Or Impact To Patient 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Unspecified Infection 52 52
Dysphagia/ Odynophagia 50 50
Nerve Damage 50 50
No Code Available 49 49
No Known Impact Or Consequence To Patient 49 49
Implant Pain 44 44
Non-union Bone Fracture 41 41
Injury 40 40
Neck Pain 39 39
Unspecified Tissue Injury 37 37
Osteolysis 35 35
Hematoma 31 31
Foreign Body In Patient 20 20
Bone Fracture(s) 19 19
Numbness 18 18
Post Operative Wound Infection 17 17
Physical Asymmetry 15 15
Hypersensitivity/Allergic reaction 12 12
Discomfort 12 12
Patient Problem/Medical Problem 11 11
Cerebrospinal Fluid Leakage 11 11
Device Embedded In Tissue or Plaque 10 10
Spinal Column Injury 10 10
Unspecified Nervous System Problem 9 9
Rash 9 9
Swelling 8 8
Inadequate Osseointegration 8 8
Hemorrhage/Bleeding 8 8
Wound Dehiscence 7 7
Swelling/ Edema 7 7
Vertebral Fracture 7 7
Decreased Sensitivity 7 7
Speech Disorder 6 6
No Patient Involvement 6 6
Perforation of Esophagus 6 6
Subluxation 5 5
Fever 5 5
Spinal Cord Injury 5 5
Skin Irritation 5 5
Inflammation 5 5
Perforation of Vessels 5 5
Muscular Rigidity 4 4
Stenosis 4 4
Low Blood Pressure/ Hypotension 4 4

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