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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
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 4
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIS ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LP
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, LLC
  SUBSTANTIALLY EQUIVALENT 2
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
EISERTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELITE SURGICAL SUPPLIES (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 2
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTELLIGENT IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAHTNU SURGICAL, 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 2
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NUTECH SPINE AND BIOLOGICS
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
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. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.,
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRISM SURGICAL DESIGN PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAPPHIRE MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINENET LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 340 340
2019 298 298
2020 400 400
2021 581 581
2022 397 398
2023 226 226

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 390 391
Adverse Event Without Identified Device or Use Problem 346 346
Migration 305 305
Break 303 303
Detachment of Device or Device Component 108 108
Device Dislodged or Dislocated 93 93
Material Integrity Problem 84 84
Migration or Expulsion of Device 83 83
Mechanical Problem 73 73
Device Slipped 61 61
Material Twisted/Bent 54 54
Insufficient Information 54 54
Material Deformation 44 44
Biocompatibility 42 42
Loosening of Implant Not Related to Bone-Ingrowth 42 42
Patient Device Interaction Problem 41 41
Device-Device Incompatibility 40 40
Material Fragmentation 36 36
Appropriate Term/Code Not Available 35 35
Compatibility Problem 33 33
Unintended Movement 30 30
Loose or Intermittent Connection 28 28
Patient-Device Incompatibility 24 24
No Apparent Adverse Event 16 16
Separation Problem 15 15
Packaging Problem 15 15
Use of Device Problem 15 15
Material Separation 14 14
Mechanical Jam 13 13
Device Damaged by Another Device 13 13
Malposition of Device 13 13
Device Operates Differently Than Expected 12 12
Material Protrusion/Extrusion 12 12
Unstable 11 11
Failure to Osseointegrate 10 10
Bent 10 10
Difficult to Remove 9 9
Off-Label Use 9 9
Positioning Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Expulsion 9 9
Naturally Worn 9 9
Mechanics Altered 8 8
Deformation Due to Compressive Stress 7 7
Inflation Problem 7 7
Difficult to Insert 7 7
Improper or Incorrect Procedure or Method 6 6
Inadequacy of Device Shape and/or Size 6 6
Detachment Of Device Component 5 5
Entrapment of Device 4 4
Dull, Blunt 4 4
Loss of Osseointegration 4 4
Failure to Advance 4 4
Osseointegration Problem 3 3
Unintended System Motion 3 3
Nonstandard Device 2 2
Product Quality Problem 2 2
Material Discolored 2 2
Defective Device 2 2
Incomplete or Missing Packaging 2 2
Device Issue 2 2
Device Fell 2 2
Material Split, Cut or Torn 2 2
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
No Tactile Prompts/Feedback 1 1
Premature Separation 1 1
Unclear Information 1 1
Device Difficult to Maintain 1 1
Noise, Audible 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Markings/Labelling Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Difficult to Advance 1 1
Unintended Ejection 1 1
Component Incompatible 1 1
Corroded 1 1
Crack 1 1
Degraded 1 1
Loss of or Failure to Bond 1 1
Device Reprocessing Problem 1 1
Peeled/Delaminated 1 1
Unexpected Therapeutic Results 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 661 662
Pain 260 260
No Known Impact Or Consequence To Patient 211 212
Failure of Implant 203 203
No Consequences Or Impact To Patient 184 184
No Code Available 172 172
Insufficient Information 139 139
Injury 100 100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
No Information 55 55
Neck Pain 48 48
Dysphagia/ Odynophagia 45 45
Nerve Damage 40 40
Non-union Bone Fracture 35 35
Unspecified Tissue Injury 31 31
Osteolysis 28 28
Unspecified Infection 27 27
Foreign Body In Patient 26 26
Device Embedded In Tissue or Plaque 25 25
Hematoma 24 24
Bone Fracture(s) 22 22
No Patient Involvement 21 21
Numbness 19 19
Discomfort 17 17
Hypersensitivity/Allergic reaction 16 16
Implant Pain 16 16
Physical Asymmetry 15 15
Spinal Column Injury 15 15
Post Operative Wound Infection 14 14
Patient Problem/Medical Problem 14 14
Swelling 13 13
Rash 11 11
Cerebrospinal Fluid Leakage 11 11
Reaction 9 9
Inadequate Osseointegration 8 8
Perforation of Esophagus 7 7
Hypoesthesia 7 7
Wound Dehiscence 7 7
Hemorrhage/Bleeding 7 7
Itching Sensation 6 6
Fall 6 6
Blood Loss 6 6
Vertebral Fracture 6 6
Not Applicable 6 6
Subluxation 5 5
Ptosis 5 5
Laceration(s) of Esophagus 5 5
Fever 5 5
Skin Irritation 5 5
Stenosis 4 5
Weakness 4 4
Muscular Rigidity 4 4
Fatigue 4 4
Cardiac Arrest 4 4
Low Blood Pressure/ Hypotension 4 4
Inflammation 4 4
Headache 4 4
Unspecified Nervous System Problem 4 4
Unspecified Musculoskeletal problem 3 3
Hernia 3 3
Impaired Healing 3 3
Neck Stiffness 3 3
Decreased Sensitivity 3 3
Ambulation Difficulties 3 3
Hair Loss 3 3
Laceration(s) 3 3
Abscess 3 3
Feeding Problem 3 3
Death 3 3
Paralysis 3 3
Neuropathy 3 3
Scar Tissue 3 3
Perforation of Vessels 3 3
Burning Sensation 2 2
Anxiety 2 2
Distress 2 2
Dysphasia 2 2
Scarring 2 2
Increased Sensitivity 2 2
Loss of Range of Motion 2 2
Pneumonia 2 2
Neurological Deficit/Dysfunction 2 2
Stroke/CVA 2 2
Foreign Body Reaction 2 2
Shaking/Tremors 2 2
Intraoperative Pain 2 2
Limited Mobility Of The Implanted Joint 2 2
Spinal Cord Injury 2 2
Depression 2 2
Joint Disorder 2 2
Eczema 2 2
Malunion of Bone 2 2
Swelling/ Edema 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Immune System Problem 1 1
Unspecified Heart Problem 1 1
Missing Value Reason 1 1
Cancer 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Jun-07-2021
2 Innovasis, Inc II May-20-2020
3 Medtronic Sofamor Danek USA Inc II May-08-2018
4 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Mar-11-2021
5 SPINEART SA II Jan-13-2018
6 Zimmer Biomet Spine Inc. II Feb-22-2019
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