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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, cranioplasty, preformed, non-alterable
Product CodeGXN
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
FIN-CERAMICA FAENZA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA SPA
  SUBSTANTIALLY EQUIVALENT 2
LONGEVITI NEURO SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 6
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 74 74
2018 56 56
2019 54 54
2020 63 63
2021 64 64
2022 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 152 152
Defective Device 44 44
Unintended Movement 16 16
Inadequacy of Device Shape and/or Size 15 15
Break 14 14
Insufficient Information 11 11
Appropriate Term/Code Not Available 10 10
Device Operates Differently Than Expected 9 9
Patient-Device Incompatibility 8 8
Fitting Problem 6 6
Defective Component 6 6
Loose or Intermittent Connection 6 6
Fracture 5 5
Material Separation 4 4
No Apparent Adverse Event 4 4
Separation Problem 4 4
Patient Device Interaction Problem 3 3
Disassembly 3 3
Contamination 3 3
Use of Device Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 2 2
Device Markings/Labelling Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Device Inoperable 2 2
Migration 2 2
Difficult to Open or Remove Packaging Material 2 2
Human Factors Issue 1 1
Incorrect Device Or Component Shipped 1 1
Positioning Problem 1 1
Device Handling Problem 1 1
Missing Information 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Melted 1 1
Crack 1 1
Decoupling 1 1
Difficult or Delayed Positioning 1 1
Failure To Adhere Or Bond 1 1
Detachment Of Device Component 1 1
Loss of Osseointegration 1 1
Detachment of Device or Device Component 1 1
Microbial Contamination of Device 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Material Distortion 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 108 108
No Code Available 73 73
No Known Impact Or Consequence To Patient 52 52
No Clinical Signs, Symptoms or Conditions 36 36
Failure of Implant 21 21
Impaired Healing 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Injury 15 15
No Consequences Or Impact To Patient 13 13
Post Operative Wound Infection 10 10
Cerebrospinal Fluid Leakage 9 9
Wound Dehiscence 6 6
Insufficient Information 6 6
Pain 5 5
No Patient Involvement 4 4
No Information 3 3
Non-union Bone Fracture 3 3
Bacterial Infection 3 3
Hematoma 3 3
Pocket Erosion 2 2
Blurred Vision 2 2
Seroma 2 2
Unspecified Tissue Injury 2 2
Tissue Breakdown 2 2
Sedation 2 2
Patient Problem/Medical Problem 1 1
Hydrocephalus 1 1
Drug Resistant Bacterial Infection 1 1
Shaking/Tremors 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Weight Changes 1 1
Meningitis 1 1
Reaction 1 1
Numbness 1 1
Swelling/ Edema 1 1
Skin Erosion 1 1
Swelling 1 1
Tissue Damage 1 1
Visual Impairment 1 1
Burning Sensation 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Paralysis 1 1
Inflammation 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Necrosis 1 1
Nerve Damage 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Extradural 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Erosion 1 1
Abscess 1 1
Edema 1 1
Eye Injury 1 1
Fatigue 1 1
Fever 1 1
Foreign Body Reaction 1 1
Hair Loss 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kelyniam Global, Inc. II May-14-2018
2 Zimmer Biomet, Inc. II Nov-06-2018
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