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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal vertebral body replacement device
Product CodeMQP
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARFTX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE
  SUBSTANTIALLY EQUIVALENT 1
CMF MEDICON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ULRICH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 117 117
2020 157 157
2021 208 208
2022 137 138
2023 71 71
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 192 192
Migration 114 114
Break 75 75
Mechanics Altered 60 60
Material Deformation 36 37
Insufficient Information 29 29
Activation Failure 27 27
Collapse 24 24
Mechanical Jam 23 23
No Apparent Adverse Event 21 21
Mechanical Problem 21 21
Migration or Expulsion of Device 21 21
Fracture 20 20
Device Dislodged or Dislocated 18 18
Appropriate Term/Code Not Available 17 17
Patient Device Interaction Problem 17 17
Material Integrity Problem 16 16
Detachment of Device or Device Component 13 13
Compatibility Problem 12 12
Material Twisted/Bent 10 10
Malposition of Device 9 9
Connection Problem 8 8
Device Slipped 7 7
Unintended Movement 7 7
Activation Problem 7 7
Use of Device Problem 6 6
Material Separation 5 5
Device-Device Incompatibility 4 4
Output Problem 4 4
Scratched Material 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Device Damaged by Another Device 3 3
Material Fragmentation 3 3
Degraded 2 2
Positioning Failure 2 2
Premature Activation 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 2 2
Activation, Positioning or Separation Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Advance 2 2
Noise, Audible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Difficult to Remove 2 2
Naturally Worn 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Overcorrection 1 1
Physical Resistance/Sticking 1 1
Failure to Cut 1 1
Structural Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Loss of Threshold 1 1
Unstable 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Difficult to Advance 1 1
Loss of or Failure to Bond 1 1
Leak/Splash 1 1
Product Quality Problem 1 1
Unintended System Motion 1 1
Disconnection 1 1
Entrapment of Device 1 1
Inflation Problem 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 293 294
No Code Available 70 70
No Known Impact Or Consequence To Patient 61 61
Insufficient Information 59 59
Pain 54 54
Failure of Implant 50 50
Non-union Bone Fracture 35 35
Nerve Damage 28 28
Unspecified Infection 25 25
Bone Fracture(s) 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Post Operative Wound Infection 18 18
Dysphagia/ Odynophagia 18 18
Hematoma 17 17
Unspecified Tissue Injury 17 17
No Consequences Or Impact To Patient 15 15
Osteolysis 14 14
Injury 11 11
Cerebrospinal Fluid Leakage 11 11
Paralysis 8 8
Perforation of Vessels 8 8
Neck Pain 6 6
Foreign Body In Patient 6 6
Physical Asymmetry 5 5
Spinal Cord Injury 5 5
Blood Loss 5 5
Therapeutic Effects, Unexpected 5 5
Hemorrhage/Bleeding 5 5
Abscess 4 4
Neuropathy 3 3
Hypersensitivity/Allergic reaction 3 3
Stenosis 3 3
Loss of consciousness 3 3
Nervous System Injury 3 3
Peripheral Nervous Injury 3 3
Thrombosis/Thrombus 3 3
Unspecified Vascular Problem 2 2
Unspecified Nervous System Problem 2 2
Speech Disorder 2 2
Vertebral Fracture 2 2
Spinal Column Injury 2 2
Reaction 2 2
Discomfort 2 2
Visual Impairment 2 2
Laceration(s) 2 2
Oversedation 2 2
Pneumonia 2 2
Edema 2 2
Extravasation 1 1
Fall 1 1
Fatigue 1 1
Fever 1 1
Fistula 1 1
Hemothorax 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Erosion 1 1
Cyst(s) 1 1
Death 1 1
Wound Dehiscence 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Seroma 1 1
Shock 1 1
Skin Irritation 1 1
Paresis 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1
Nausea 1 1
Hypovolemic Shock 1 1
Neurological Deficit/Dysfunction 1 1
Impaired Healing 1 1
Inadequate Pain Relief 1 1
Perforation of Esophagus 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Rupture 1 1
Myalgia 1 1
Hernia 1 1
Numbness 1 1
Depression 1 1
Abdominal Distention 1 1
Ptosis 1 1
No Patient Involvement 1 1
Osteopenia/ Osteoporosis 1 1
Bowel Perforation 1 1
Tissue Breakdown 1 1
Decreased Sensitivity 1 1
Intervertebral Disc Compression or Protrusion 1 1
Swelling/ Edema 1 1
Paresthesia 1 1
Cancer 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Renal Impairment 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Paraplegia 1 1
Choking 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NuVasive Inc II Dec-20-2022
2 Synthes (USA) Products LLC III Nov-05-2020
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