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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
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 1
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 183 183
Migration 109 109
Break 73 73
Mechanics Altered 60 60
Material Deformation 36 37
Activation Failure 27 27
Mechanical Jam 22 22
Collapse 22 22
Migration or Expulsion of Device 21 21
No Apparent Adverse Event 21 21
Fracture 20 20
Device Dislodged or Dislocated 17 17
Appropriate Term/Code Not Available 17 17
Material Integrity Problem 16 16
Insufficient Information 15 15
Patient Device Interaction Problem 15 15
Mechanical Problem 13 13
Compatibility Problem 12 12
Detachment of Device or Device Component 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
Device-Device Incompatibility 4 4
Material Separation 4 4
Output Problem 4 4
Scratched Material 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Material Fragmentation 3 3
Device Damaged by Another Device 3 3
Activation, Positioning or Separation Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Advance 2 2
Degraded 2 2
Positioning Failure 2 2
Premature Activation 2 2
Loose or Intermittent Connection 2 2
Difficult to Insert 2 2
Noise, Audible 2 2
Therapeutic or Diagnostic Output Failure 2 2
Naturally Worn 2 2
Overcorrection 1 1
Physical Resistance/Sticking 1 1
Leak/Splash 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1
Disconnection 1 1
Entrapment of Device 1 1
Inflation Problem 1 1
Crack 1 1
Failure to Cut 1 1
Patient-Device Incompatibility 1 1
Biocompatibility 1 1
Structural Problem 1 1
Loss of Threshold 1 1
Unstable 1 1
Difficult to Advance 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 281 282
No Code Available 70 70
No Known Impact Or Consequence To Patient 61 61
Pain 52 52
Failure of Implant 45 45
Insufficient Information 34 34
Non-union Bone Fracture 32 32
Nerve Damage 27 27
Unspecified Infection 22 22
Bone Fracture(s) 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Post Operative Wound Infection 18 18
Dysphagia/ Odynophagia 16 16
No Consequences Or Impact To Patient 15 15
Unspecified Tissue Injury 15 15
Osteolysis 14 14
Hematoma 14 14
Injury 11 11
Cerebrospinal Fluid Leakage 9 9
Paralysis 8 8
Perforation of Vessels 7 7
Foreign Body In Patient 6 6
Neck Pain 6 6
Physical Asymmetry 5 5
Therapeutic Effects, Unexpected 5 5
Blood Loss 5 5
Abscess 4 4
Spinal Cord Injury 4 4
Loss of consciousness 3 3
Peripheral Nervous Injury 3 3
Hemorrhage/Bleeding 3 3
Neuropathy 3 3
Hypersensitivity/Allergic reaction 3 3
Stenosis 3 3
Discomfort 2 2
Visual Impairment 2 2
Reaction 2 2
Laceration(s) 2 2
Oversedation 2 2
Pneumonia 2 2
Edema 2 2
Vertebral Fracture 2 2
Unspecified Vascular Problem 2 2
Nervous System Injury 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Cancer 1 1
Renal Impairment 1 1
Paresthesia 1 1
Unspecified Nervous System Problem 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Swelling/ Edema 1 1
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
Seroma 1 1
Shock 1 1
Skin Irritation 1 1
Spinal Column Injury 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
Numbness 1 1
Depression 1 1
Paraplegia 1 1
Choking 1 1
Respiratory Failure 1 1
Ambulation Difficulties 1 1
Confusion/ Disorientation 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
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

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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