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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 1
KONTOUR(XI’AN) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LONGEVITI NEURO SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 6
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 54 54
2020 63 63
2021 63 63
2022 57 57
2023 32 32
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 159 159
Defective Device 62 62
Insufficient Information 13 13
Break 11 11
Appropriate Term/Code Not Available 11 11
Inadequacy of Device Shape and/or Size 7 7
Defective Component 6 6
No Apparent Adverse Event 5 5
Separation Problem 4 4
Material Separation 4 4
Migration 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Open or Remove Packaging Material 2 2
Crack 2 2
Device Markings/Labelling Problem 2 2
Patient Device Interaction Problem 2 2
Product Quality Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Fracture 2 2
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Incomplete or Missing Packaging 1 1
Material Erosion 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Use of Device Problem 1 1
Difficult or Delayed Positioning 1 1
Decoupling 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Melted 1 1
Difficult to Open or Close 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 122 122
No Clinical Signs, Symptoms or Conditions 55 55
No Code Available 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Insufficient Information 16 16
Post Operative Wound Infection 14 14
No Known Impact Or Consequence To Patient 14 14
Injury 14 14
Failure of Implant 12 12
Impaired Healing 6 6
Wound Dehiscence 6 6
No Consequences Or Impact To Patient 6 6
Cerebrospinal Fluid Leakage 5 5
Unspecified Tissue Injury 4 4
Non-union Bone Fracture 4 4
No Patient Involvement 4 4
Pain 4 4
Hematoma 3 3
Tissue Breakdown 2 2
Pocket Erosion 2 2
Bacterial Infection 2 2
No Information 2 2
Swelling/ Edema 2 2
Eye Pain 1 1
Hemorrhage/Bleeding 1 1
Erosion 1 1
Blurred Vision 1 1
Tissue Damage 1 1
Hydrocephalus 1 1
Abscess 1 1
Visual Impairment 1 1
Hair Loss 1 1
Fall 1 1
Numbness 1 1
Swelling 1 1
Nerve Damage 1 1
Skin Erosion 1 1
Paralysis 1 1
Intracranial Hemorrhage 1 1
Cognitive Changes 1 1
Edema 1 1
Inflammation 1 1
Metal Related Pathology 1 1
Seizures 1 1
Hemorrhage, Extradural 1 1
Drug Resistant Bacterial Infection 1 1
Dry Mouth 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Infection 1 1

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