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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
Regulation Description Spinal intervertebral body fixation orthosis.
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
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOUNDATION SURGICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 157 157
2021 208 208
2022 137 138
2023 71 71
2024 97 97
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 170 170
Migration 99 99
Break 72 72
Mechanics Altered 63 63
Material Deformation 40 41
Mechanical Problem 39 39
Insufficient Information 29 29
Collapse 29 29
Activation Failure 27 27
Mechanical Jam 24 24
No Apparent Adverse Event 18 18
Patient Device Interaction Problem 18 18
Material Integrity Problem 16 16
Fracture 14 14
Device Dislodged or Dislocated 12 12
Compatibility Problem 12 12
Detachment of Device or Device Component 10 10
Migration or Expulsion of Device 10 10
Connection Problem 8 8
Material Twisted/Bent 8 8
Malposition of Device 8 8
Unintended Movement 7 7
Activation Problem 7 7
Use of Device Problem 6 6
Appropriate Term/Code Not Available 5 5
Material Separation 4 4
Output Problem 4 4
Failure to Advance 4 4
Device Slipped 4 4
Device Damaged by Another Device 3 3
Scratched Material 3 3
Product Quality Problem 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Noise, Audible 2 2
Improper or Incorrect Procedure or Method 2 2
Loose or Intermittent Connection 2 2
Positioning Failure 2 2
Premature Activation 2 2
Difficult to Remove 2 2
Activation, Positioning or Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Naturally Worn 2 2
Degraded 2 2
Device-Device Incompatibility 1 1
Biocompatibility 1 1
Patient-Device Incompatibility 1 1
Structural Problem 1 1
Loss of Threshold 1 1
Difficult to Advance 1 1
Material Fragmentation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 334 335
Insufficient Information 67 67
Pain 47 47
No Known Impact Or Consequence To Patient 43 43
Failure of Implant 37 37
Non-union Bone Fracture 35 35
No Code Available 32 32
Bone Fracture(s) 24 24
Nerve Damage 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Post Operative Wound Infection 20 20
Unspecified Infection 18 18
Unspecified Tissue Injury 17 17
Hematoma 17 17
Dysphagia/ Odynophagia 16 16
Osteolysis 14 14
Cerebrospinal Fluid Leakage 12 12
Perforation of Vessels 8 8
Hemorrhage/Bleeding 8 8
No Consequences Or Impact To Patient 7 7
Neck Pain 6 6
Therapeutic Effects, Unexpected 5 5
Physical Asymmetry 5 5
Injury 5 5
Spinal Cord Injury 5 5
Blood Loss 4 4
Stenosis 4 4
Nervous System Injury 4 4
Paralysis 4 4
Thrombosis/Thrombus 3 3
Pneumothorax 3 3
Foreign Body In Patient 3 3
Loss of consciousness 3 3
Peripheral Nervous Injury 3 3
Neuropathy 3 3
Hypersensitivity/Allergic reaction 3 3
Abscess 2 2
Spinal Column Injury 2 2
Pleural Effusion 2 2
Oversedation 2 2
Laceration(s) 2 2
Ambulation Difficulties 2 2
Vertebral Fracture 2 2
Impaired Healing 2 2
Speech Disorder 2 2
Inadequate Osseointegration 2 2
Unspecified Vascular Problem 2 2
Unspecified Nervous System Problem 2 2
Hypovolemic Shock 1 1
Hemothorax 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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