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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 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 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 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 2
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
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
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 591 606
2022 392 401
2023 320 324
2024 419 421
2025 250 250

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 419 420
Migration 378 380
Adverse Event Without Identified Device or Use Problem 340 360
Break 237 239
Material Integrity Problem 126 127
Device Dislodged or Dislocated 106 106
Detachment of Device or Device Component 95 97
Insufficient Information 87 91
Mechanical Problem 64 64
Patient Device Interaction Problem 63 63
Device Slipped 62 62
Material Twisted/Bent 52 54
Compatibility Problem 51 51
Material Deformation 48 49
Loosening of Implant Not Related to Bone-Ingrowth 46 46
Material Fragmentation 38 38
Biocompatibility 33 33
Migration or Expulsion of Device 32 32
Device-Device Incompatibility 28 29
Patient-Device Incompatibility 28 31
Device Appears to Trigger Rejection 24 24
Material Separation 22 22
Appropriate Term/Code Not Available 19 19
No Apparent Adverse Event 15 15
Wrong Label 14 14
Use of Device Problem 14 14
Difficult to Insert 14 14
Separation Problem 13 13
Packaging Problem 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
Activation, Positioning or Separation Problem 7 7
Positioning Problem 7 7
Defective Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Human-Device Interface Problem 7 7
Failure to Osseointegrate 6 6
Unintended Movement 6 6
Product Quality Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 980 987
Insufficient Information 336 346
Failure of Implant 222 227
Pain 218 223
No Consequences Or Impact To Patient 103 103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 87 88
Nerve Damage 59 61
Dysphagia/ Odynophagia 54 54
Unspecified Infection 53 54
Non-union Bone Fracture 50 51
No Known Impact Or Consequence To Patient 49 49
Implant Pain 49 49
No Code Available 49 49
Unspecified Tissue Injury 49 49
Neck Pain 46 46
Injury 40 40
Osteolysis 40 50
Hematoma 36 38
Numbness 29 32
Foreign Body In Patient 26 26
Bone Fracture(s) 21 21
Post Operative Wound Infection 19 19
Physical Asymmetry 15 16
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 11
Hemorrhage/Bleeding 10 10
Vertebral Fracture 9 9
Rash 9 9
Unspecified Nervous System Problem 9 9
Decreased Sensitivity 8 10
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 6
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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