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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 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES LLC
  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 2
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
EFFORTMED, LLC
  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
FELLOWSHIP OF ORTHOPAEDIC RESEARCHERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
INDIUS MEDICAL TECHNOLOGIES PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  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 1
MEDITECH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 3
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 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 4
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
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINENET LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
2019 298 298
2020 400 400
2021 581 581
2022 395 396
2023 318 318
2024 161 161

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 377 378
Adverse Event Without Identified Device or Use Problem 315 315
Migration 307 307
Break 239 239
Detachment of Device or Device Component 100 100
Material Integrity Problem 96 96
Device Dislodged or Dislocated 94 94
Insufficient Information 68 68
Mechanical Problem 62 62
Device Slipped 61 61
Material Deformation 56 56
Migration or Expulsion of Device 54 54
Material Twisted/Bent 51 51
Patient Device Interaction Problem 50 50
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Compatibility Problem 42 42
Biocompatibility 39 39
Material Fragmentation 37 37
Appropriate Term/Code Not Available 32 32
Device-Device Incompatibility 29 29
Patient-Device Incompatibility 27 27
Device Appears to Trigger Rejection 24 24
Material Separation 18 18
No Apparent Adverse Event 18 18
Loose or Intermittent Connection 15 15
Device Damaged by Another Device 15 15
Packaging Problem 15 15
Separation Problem 12 12
Mechanical Jam 11 11
Unstable 11 11
Use of Device Problem 10 10
Unintended Movement 10 10
Malposition of Device 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Expulsion 9 9
Mechanics Altered 9 9
Improper or Incorrect Procedure or Method 9 9
Off-Label Use 9 9
Inflation Problem 9 9
Failure to Osseointegrate 8 8
Difficult to Remove 7 7
Inadequacy of Device Shape and/or Size 7 7
Material Protrusion/Extrusion 7 7
Positioning Problem 7 7
Misassembly by Users 6 6
Human-Device Interface Problem 6 6
Difficult to Insert 6 6
Entrapment of Device 6 6
Product Quality Problem 5 5
Loss of Osseointegration 4 4
Deformation Due to Compressive Stress 4 4
Osseointegration Problem 3 3
Naturally Worn 3 3
Failure to Advance 3 3
Unintended System Motion 3 3
Wrong Label 3 3
Material Split, Cut or Torn 2 2
Nonstandard Device 2 2
Material Discolored 2 2
Defective Device 2 2
Incomplete or Missing Packaging 2 2
Noise, Audible 2 2
Activation, Positioning or Separation Problem 2 2
Device Markings/Labelling Problem 1 1
Connection Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Device Difficult to Maintain 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Dull, Blunt 1 1
Component Missing 1 1
Unexpected Therapeutic Results 1 1
Loss of or Failure to Bond 1 1
Unintended Ejection 1 1
Device Reprocessing Problem 1 1
Component Incompatible 1 1
Corroded 1 1
Crack 1 1
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
No Tactile Prompts/Feedback 1 1
Premature Separation 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 731 732
Insufficient Information 214 214
Pain 213 213
Failure of Implant 206 206
No Consequences Or Impact To Patient 167 167
No Known Impact Or Consequence To Patient 122 122
No Code Available 98 98
Injury 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 76 76
Dysphagia/ Odynophagia 47 47
Neck Pain 45 45
Implant Pain 43 43
Nerve Damage 42 42
Unspecified Infection 41 41
Non-union Bone Fracture 39 39
Unspecified Tissue Injury 36 36
Osteolysis 34 34
Hematoma 30 30
Foreign Body In Patient 26 26
No Information 23 23
Device Embedded In Tissue or Plaque 20 20
Bone Fracture(s) 19 19
Discomfort 19 19
Numbness 18 18
No Patient Involvement 16 16
Physical Asymmetry 15 15
Post Operative Wound Infection 14 14
Patient Problem/Medical Problem 12 12
Hypersensitivity/Allergic reaction 12 12
Cerebrospinal Fluid Leakage 10 10
Rash 10 10
Spinal Column Injury 9 9
Swelling 9 9
Inadequate Osseointegration 8 8
Perforation of Esophagus 8 8
Reaction 7 7
Decreased Sensitivity 7 7
Swelling/ Edema 7 7
Wound Dehiscence 7 7
Hemorrhage/Bleeding 7 7
Vertebral Fracture 6 6
Laceration(s) of Esophagus 6 6
Ptosis 5 5
Blood Loss 5 5
Speech Disorder 5 5
Subluxation 5 5
Fall 5 5
Fever 5 5
Skin Irritation 5 5
Perforation of Vessels 5 5
Neuropathy 4 4
Low Blood Pressure/ Hypotension 4 4
Muscular Rigidity 4 4
Unspecified Nervous System Problem 4 4
Spinal Cord Injury 4 4
Neck Stiffness 3 3
Thrombosis/Thrombus 3 3
Intraoperative Pain 3 3
Unspecified Musculoskeletal problem 3 3
Inflammation 3 3
Laceration(s) 3 3
Feeding Problem 3 3
Headache 3 3
Cardiac Arrest 3 3
Abscess 3 3
Paralysis 3 3
Scar Tissue 3 3
Weakness 3 3
Dysphasia 3 3
Hernia 3 3
Stenosis 3 3
Joint Disorder 2 2
Depression 2 2
Pneumonia 2 2
Loss of Range of Motion 2 2
Pulmonary Embolism 2 2
Stroke/CVA 2 2
Fatigue 2 2
Hair Loss 2 2
Neurological Deficit/Dysfunction 2 2
Eczema 2 2
Joint Laxity 2 2
Thromboembolism 2 2
Not Applicable 2 2
Impaired Healing 2 2
Shaking/Tremors 2 2
Ambulation Difficulties 2 2
Respiratory Failure 1 1
Abdominal Distention 1 1
Pseudoaneurysm 1 1
Unspecified Heart Problem 1 1
Unspecified Immune System Problem 1 1
Paresthesia 1 1
Missing Value Reason 1 1
Convulsion/Seizure 1 1
Malunion of Bone 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Intervertebral Disc Compression or Protrusion 1 1
Nausea 1 1
Head Injury 1 1

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
4 Zimmer Biomet Spine Inc. II Feb-22-2019
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