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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 4
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
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 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 2
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
  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
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 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 400 402
2021 591 591
2022 392 393
2023 320 320
2024 419 419
2025 206 206

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 413 414
Migration 372 372
Adverse Event Without Identified Device or Use Problem 332 332
Break 228 228
Material Integrity Problem 125 125
Device Dislodged or Dislocated 103 103
Detachment of Device or Device Component 95 97
Insufficient Information 85 85
Mechanical Problem 64 64
Device Slipped 62 62
Patient Device Interaction Problem 62 62
Compatibility Problem 51 51
Material Deformation 48 48
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Material Twisted/Bent 45 45
Material Fragmentation 38 38
Biocompatibility 33 33
Migration or Expulsion of Device 32 32
Device-Device Incompatibility 28 28
Patient-Device Incompatibility 28 28
Device Appears to Trigger Rejection 24 24
Material Separation 22 22
Appropriate Term/Code Not Available 19 19
No Apparent Adverse Event 15 15
Use of Device Problem 14 14
Difficult to Insert 14 14
Separation Problem 13 13
Packaging Problem 13 13
Wrong Label 13 13
Inflation Problem 13 13
Unstable 11 11
Mechanical Jam 10 10
Loose or Intermittent Connection 10 10
Mechanics Altered 9 9
Device Damaged by Another Device 9 9
Expulsion 9 9
Manufacturing, Packaging or Shipping Problem 8 8
Misassembly by Users 8 8
Improper or Incorrect Procedure or Method 8 8
Entrapment of Device 8 8
Off-Label Use 8 8
Malposition of Device 8 8
Positioning Problem 7 7
Inadequacy of Device Shape and/or Size 7 7
Human-Device Interface Problem 7 7
Activation, Positioning or Separation Problem 6 6
Failure to Osseointegrate 6 6
Material Protrusion/Extrusion 6 6
Product Quality Problem 5 5
Unintended Movement 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 962 963
Insufficient Information 331 331
Failure of Implant 217 217
Pain 212 214
No Consequences Or Impact To Patient 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 85 85
Nerve Damage 59 59
Unspecified Infection 53 53
Dysphagia/ Odynophagia 53 53
No Known Impact Or Consequence To Patient 49 49
No Code Available 49 49
Unspecified Tissue Injury 49 49
Implant Pain 48 48
Non-union Bone Fracture 48 48
Neck Pain 41 41
Injury 40 40
Osteolysis 38 38
Hematoma 36 36
Numbness 25 27
Foreign Body In Patient 24 24
Bone Fracture(s) 21 21
Post Operative Wound Infection 19 19
Physical Asymmetry 15 15
Cerebrospinal Fluid Leakage 13 13
Spinal Column Injury 13 13
Device Embedded In Tissue or Plaque 13 13
Hypersensitivity/Allergic reaction 12 12
Discomfort 12 12
Patient Problem/Medical Problem 11 11
Inadequate Osseointegration 10 10
Hemorrhage/Bleeding 10 10
Vertebral Fracture 9 9
Rash 9 9
Unspecified Nervous System Problem 9 9
Decreased Sensitivity 8 8
Swelling 8 8
Swelling/ Edema 7 7
Wound Dehiscence 7 7
Speech Disorder 6 6
Perforation of Vessels 6 6
Perforation of Esophagus 6 6
Inflammation 6 6
No Patient Involvement 6 6
Loss of Range of Motion 6 6
Skin Irritation 5 5
Joint Laxity 5 5
Subluxation 5 5
Muscle Weakness 5 5
Spinal Cord Injury 5 5
Fever 5 5

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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