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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
Regulation Description Preformed nonalterable cranioplasty plate.
Product CodeGXN
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
FIN-CERAMICA FAENZA SPA
  SUBSTANTIALLY EQUIVALENT 3
FLEXTRONICS INTERNATIONAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH and CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 47 47
2016 33 33
2017 74 74
2018 56 56
2019 54 54
2020 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 123 123
Inadequacy of Device Shape and/or Size 25 25
Device Operates Differently Than Expected 19 19
Unintended Movement 17 17
Fitting Problem 14 14
Defective Device 14 14
Insufficient Information 12 12
Break 11 11
Appropriate Term/Code Not Available 10 10
Patient-Device Incompatibility 8 8
Loose or Intermittent Connection 8 8
Failure To Adhere Or Bond 6 6
Fracture 6 6
Defective Component 5 5
Material Deformation 5 5
Disassembly 4 4
Material Separation 4 4
Separation Problem 4 4
No Apparent Adverse Event 3 3
Patient Device Interaction Problem 3 3
Use of Device Problem 3 3
Material Integrity Problem 3 3
Contamination 3 3
Device Inoperable 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Material Distortion 2 2
Device Markings/Labelling Problem 2 2
Incorrect Device Or Component Shipped 1 1
Malposition of Device 1 1
Product Quality Problem 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Detachment Of Device Component 1 1
Migration 1 1
Missing Information 1 1
Positioning Problem 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Shipping Damage or Problem 1 1
Device Operational Issue 1 1
Difficult to Open or Close 1 1
Human Factors Issue 1 1
Plate 1 1
Crack 1 1
Material Fragmentation 1 1
Mechanical Problem 1 1
Difficult To Position 1 1
Detachment of Device or Device Component 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 106 106
No Code Available 83 83
No Known Impact Or Consequence To Patient 83 83
Impaired Healing 16 16
Failure of Implant 15 15
Injury 14 14
No Consequences Or Impact To Patient 12 12
Sedation 8 8
Pain 7 7
Bacterial Infection 6 6
No Information 6 6
Wound Dehiscence 5 5
Cerebrospinal Fluid Leakage 5 5
Reaction 4 4
No Patient Involvement 4 4
Post Operative Wound Infection 2 2
Seroma 2 2
Pocket Erosion 2 2
Necrosis 2 2
Inflammation 2 2
Swelling 2 2
Erosion 1 1
Ambulation Difficulties 1 1
Fluid Discharge 1 1
Memory Loss/Impairment 1 1
Staphylococcus Aureus 1 1
Skin Erosion 1 1
Fatigue 1 1
Fever 1 1
Hemorrhage, Extradural 1 1
Hypersensitivity/Allergic reaction 1 1
Adhesion(s) 1 1
Nausea 1 1
Seizures 1 1
Paralysis 1 1
Death 1 1
Edema 1 1
Eye Injury 1 1
Fistula 1 1
Foreign Body Reaction 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Tissue Damage 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Burning Sensation 1 1
Non-union Bone Fracture 1 1
Meningitis 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Weight Changes 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Hydrocephalus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kelyniam Global, Inc. II May-14-2018
2 Synthes (USA) Products LLC II Sep-23-2015
3 Zimmer Biomet, Inc. II Nov-06-2018
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