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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
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOARCHITECTS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA SPA
  SUBSTANTIALLY EQUIVALENT 3
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KELYNIAM GLOBAL, INC
  SUBSTANTIALLY EQUIVALENT 1
KELYNIAM GLOBAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
KONTOUR(XI’AN) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LONGEVITI NEURO SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 7
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSDSIGN AB
  SUBSTANTIALLY EQUIVALENT 1
OSTEOSYMBIONICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
OXFORD PERFORMANCE MATERIALS
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
VANDUZEN DBA MEDCAD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 60 60
2015 47 47
2016 33 33
2017 74 74
2018 56 56
2019 54 54
2020 63 63
2021 63 63
2022 57 57
2023 32 32
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 239 239
Defective Device 60 60
Inadequacy of Device Shape and/or Size 36 36
Insufficient Information 34 34
Device Operates Differently Than Expected 22 22
Break 21 21
Fitting Problem 18 18
Appropriate Term/Code Not Available 17 17
Unintended Movement 17 17
Patient-Device Incompatibility 8 8
Loose or Intermittent Connection 8 8
Fracture 6 6
Use of Device Problem 6 6
Defective Component 6 6
Failure To Adhere Or Bond 6 6
Material Deformation 5 5
No Apparent Adverse Event 5 5
Separation Problem 4 4
Material Separation 4 4
Disassembly 4 4
Contamination 3 3
Difficult To Position 3 3
Device Inoperable 3 3
Improper or Incorrect Procedure or Method 3 3
Patient Device Interaction Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Positioning Problem 2 2
Material Distortion 2 2
Device Markings/Labelling Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Migration 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Crack 2 2
Detachment Of Device Component 2 2
Component Falling 1 1
Material Erosion 1 1
Decoupling 1 1
Difficult or Delayed Positioning 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Loss of Osseointegration 1 1
Detachment of Device or Device Component 1 1
Malposition of Device 1 1
Shipping Damage or Problem 1 1
Microbial Contamination of Device 1 1
Incomplete or Missing Packaging 1 1
Device Issue 1 1
Missing Information 1 1
Device Handling Problem 1 1
Human Factors Issue 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Device Operational Issue 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 190 190
No Code Available 98 98
No Known Impact Or Consequence To Patient 97 97
No Clinical Signs, Symptoms or Conditions 53 53
Failure of Implant 22 22
Impaired Healing 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Injury 15 15
No Consequences Or Impact To Patient 14 14
Post Operative Wound Infection 14 14
Pain 14 14
Insufficient Information 11 11
No Information 10 10
Sedation 10 10
Cerebrospinal Fluid Leakage 10 10
Wound Dehiscence 7 7
Bacterial Infection 7 7
Non-union Bone Fracture 4 4
No Patient Involvement 4 4
Reaction 4 4
Unspecified Tissue Injury 3 3
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Emotional Changes 3 3
Abscess 2 2
Necrosis 2 2
Inflammation 2 2
Paralysis 2 2
Pocket Erosion 2 2
Seroma 2 2
Swelling 2 2
Swelling/ Edema 2 2
Hydrocephalus 2 2
Tissue Breakdown 2 2
Fluid Discharge 2 2
Blurred Vision 2 2
Visual Impairment 1 1
Burning Sensation 1 1
Discharge 1 1
Meningitis 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 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
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1
Numbness 1 1
Tissue Damage 1 1
Skin Erosion 1 1
Staphylococcus Aureus 1 1
Seizures 1 1
Laceration(s) 1 1
Memory Loss/Impairment 1 1
Nausea 1 1
Nerve Damage 1 1
Death 1 1
Edema 1 1
Adhesion(s) 1 1
Erosion 1 1
Hemorrhage, Extradural 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Eye Injury 1 1
Fall 1 1
Fatigue 1 1
Fever 1 1
Fistula 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 Synthes (USA) Products LLC II Sep-23-2015
3 Zimmer Biomet, Inc. II Nov-06-2018
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