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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 143 143
Defective Device 57 57
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
Material Separation 4 4
Separation Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Device Markings/Labelling Problem 2 2
Crack 2 2
Difficult to Open or Remove Packaging Material 2 2
Patient Device Interaction Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Migration 2 2
Material Integrity Problem 1 1
Decoupling 1 1
Missing Information 1 1
Fracture 1 1
Difficult to Open or Close 1 1
Use of Device Problem 1 1
Melted 1 1
Difficult or Delayed Positioning 1 1
Material Fragmentation 1 1
Incomplete or Missing Packaging 1 1
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Loss of Osseointegration 1 1
Microbial Contamination of Device 1 1
Detachment of Device or Device Component 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 108 108
No Clinical Signs, Symptoms or Conditions 53 53
No Code Available 41 41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Injury 14 14
No Known Impact Or Consequence To Patient 14 14
Failure of Implant 12 12
Insufficient Information 11 11
Post Operative Wound Infection 10 10
Impaired Healing 6 6
No Consequences Or Impact To Patient 6 6
Wound Dehiscence 6 6
Cerebrospinal Fluid Leakage 5 5
Non-union Bone Fracture 4 4
No Patient Involvement 4 4
Pain 3 3
Hematoma 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 2 2
Bacterial Infection 2 2
No Information 2 2
Pocket Erosion 2 2
Seizures 1 1
Skin Erosion 1 1
Swelling 1 1
Tissue Damage 1 1
Blurred Vision 1 1
Visual Impairment 1 1
Tissue Breakdown 1 1
Numbness 1 1
Cognitive Changes 1 1
Erosion 1 1
Abscess 1 1
Edema 1 1
Fall 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Hemorrhage, Extradural 1 1
Intracranial Hemorrhage 1 1
Hypersensitivity/Allergic reaction 1 1
Paralysis 1 1
Inflammation 1 1
Nerve Damage 1 1
Hydrocephalus 1 1
Skin Infection 1 1
Drug Resistant Bacterial Infection 1 1

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