Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 247 247

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 388 389
Adverse Event Without Identified Device or Use Problem 320 320
Migration 319 319
Break 248 248
Material Integrity Problem 111 111
Detachment of Device or Device Component 101 101
Device Dislodged or Dislocated 98 98
Insufficient Information 74 74
Device Slipped 69 69
Mechanical Problem 65 65
Material Deformation 58 58
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 45 45
Compatibility Problem 43 43
Biocompatibility 39 39
Material Fragmentation 38 38
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
Misassembly by Users 8 8
Positioning Problem 7 7
Material Protrusion/Extrusion 7 7
Difficult to Remove 7 7
Inadequacy of Device Shape and/or Size 7 7
Difficult to Insert 6 6
Entrapment of Device 6 6
Human-Device Interface Problem 6 6
Wrong Label 6 6
Product Quality Problem 5 5
Loss of Osseointegration 4 4
Deformation Due to Compressive Stress 4 4
Activation, Positioning or Separation Problem 3 3
Osseointegration Problem 3 3
Naturally Worn 3 3
Failure to Advance 3 3
Material Discolored 3 3
Unintended System Motion 3 3
Nonstandard Device 2 2
Defective Device 2 2
Incomplete or Missing Packaging 2 2
Noise, Audible 2 2
Material Split, Cut or Torn 2 2
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
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Maintain 1 1
Output Problem 1 1
Device Markings/Labelling Problem 1 1
Connection Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 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
Fluid/Blood Leak 1 1
Device Reprocessing Problem 1 1
Component Incompatible 1 1
Corroded 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 784 785
Insufficient Information 227 227
Pain 219 219
Failure of Implant 211 211
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
Unspecified Infection 51 51
Dysphagia/ Odynophagia 49 49
Neck Pain 45 45
Implant Pain 43 43
Nerve Damage 42 42
Non-union Bone Fracture 41 41
Unspecified Tissue Injury 36 36
Osteolysis 34 34
Hematoma 32 32
Foreign Body In Patient 27 27
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 12 12
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
Speech Disorder 6 6
Unspecified Nervous System Problem 6 6
Spinal Cord Injury 6 6
Laceration(s) of Esophagus 6 6
Ptosis 5 5
Blood Loss 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
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
Unspecified Musculoskeletal problem 3 3
Neck Stiffness 3 3
Thrombosis/Thrombus 3 3
Intraoperative Pain 3 3
Thromboembolism 2 2
Not Applicable 2 2
Impaired Healing 2 2
Shaking/Tremors 2 2
Ambulation Difficulties 2 2
Eczema 2 2
Joint Laxity 2 2
Intervertebral Disc Compression or Protrusion 2 2
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
Nausea 1 1
Head Injury 1 1
Fistula 1 1
Foreign Body Reaction 1 1
Erythema 1 1
Exsanguination 1 1
Abdominal Pain 1 1
Aspiration/Inhalation 1 1
Calcium Deposits/Calcification 1 1
Chest Pain 1 1
Crushing Injury 1 1
Death 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
-
-