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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
JEIL MEDICAL CORPORATION
  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.
  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
STRYKER SPINE
  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 346 346

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 402 403
Migration 344 344
Adverse Event Without Identified Device or Use Problem 333 333
Break 256 256
Material Integrity Problem 116 116
Detachment of Device or Device Component 104 104
Device Dislodged or Dislocated 102 102
Insufficient Information 82 82
Device Slipped 69 69
Mechanical Problem 68 68
Material Deformation 58 58
Material Twisted/Bent 58 58
Migration or Expulsion of Device 54 54
Patient Device Interaction Problem 50 50
Loosening of Implant Not Related to Bone-Ingrowth 45 45
Compatibility Problem 43 43
Biocompatibility 40 40
Material Fragmentation 38 38
Appropriate Term/Code Not Available 32 32
Device-Device Incompatibility 31 31
Patient-Device Incompatibility 27 27
Device Appears to Trigger Rejection 24 24
No Apparent Adverse Event 19 19
Material Separation 18 18
Loose or Intermittent Connection 15 15
Packaging Problem 15 15
Device Damaged by Another Device 15 15
Wrong Label 13 13
Difficult to Insert 13 13
Mechanical Jam 12 12
Separation Problem 12 12
Unstable 11 11
Unintended Movement 11 11
Inflation Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Use of Device Problem 10 10
Malposition of Device 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Expulsion 9 9
Off-Label Use 9 9
Mechanics Altered 9 9
Misassembly by Users 8 8
Failure to Osseointegrate 8 8
Material Protrusion/Extrusion 7 7
Inadequacy of Device Shape and/or Size 7 7
Difficult to Remove 7 7
Positioning Problem 7 7
Entrapment of Device 6 6
Activation, Positioning or Separation Problem 6 6
Human-Device Interface Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 833 834
Insufficient Information 248 248
Pain 226 226
Failure of Implant 219 219
No Consequences Or Impact To Patient 167 167
No Known Impact Or Consequence To Patient 122 122
No Code Available 98 98
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Injury 77 77
Dysphagia/ Odynophagia 54 54
Unspecified Infection 53 53
Neck Pain 46 46
Non-union Bone Fracture 43 43
Nerve Damage 43 43
Implant Pain 43 43
Unspecified Tissue Injury 37 37
Osteolysis 35 35
Hematoma 32 32
Foreign Body In Patient 30 30
No Information 23 23
Discomfort 22 22
Device Embedded In Tissue or Plaque 20 20
Bone Fracture(s) 19 19
Numbness 18 18
No Patient Involvement 16 16
Physical Asymmetry 15 15
Post Operative Wound Infection 15 15
Cerebrospinal Fluid Leakage 13 13
Hypersensitivity/Allergic reaction 12 12
Patient Problem/Medical Problem 12 12
Rash 10 10
Spinal Column Injury 10 10
Perforation of Esophagus 9 9
Swelling 9 9
Inadequate Osseointegration 8 8
Hemorrhage/Bleeding 8 8
Swelling/ Edema 7 7
Decreased Sensitivity 7 7
Reaction 7 7
Vertebral Fracture 7 7
Wound Dehiscence 7 7
Speech Disorder 6 6
Inflammation 6 6
Spinal Cord Injury 6 6
Laceration(s) of Esophagus 6 6
Unspecified Nervous System Problem 6 6
Skin Irritation 5 5
Fall 5 5
Subluxation 5 5
Blood Loss 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
4 Zimmer Biomet Spine Inc. II Feb-22-2019
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