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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 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
2020 63 63
2021 63 63
2022 57 57
2023 32 32
2024 35 35
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 144 144
Defective Device 56 56
Insufficient Information 12 12
Break 11 11
Appropriate Term/Code Not Available 7 7
Defective Component 6 6
Inadequacy of Device Shape and/or Size 3 3
Migration 3 3
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Fitting Problem 1 1
Device-Device Incompatibility 1 1
Incomplete or Missing Packaging 1 1
Crack 1 1
Material Erosion 1 1
Material Integrity Problem 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Difficult or Delayed Positioning 1 1
Decoupling 1 1
Product Quality Problem 1 1
Missing Information 1 1
Melted 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 105 105
No Clinical Signs, Symptoms or Conditions 55 55
No Code Available 21 21
Insufficient Information 18 18
Post Operative Wound Infection 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Injury 10 10
Failure of Implant 9 9
No Known Impact Or Consequence To Patient 6 6
Cerebrospinal Fluid Leakage 5 5
Unspecified Tissue Injury 4 4
Impaired Healing 3 3
Wound Dehiscence 3 3
No Consequences Or Impact To Patient 3 3
Hematoma 3 3
Non-union Bone Fracture 3 3
Pain 3 3
Tissue Breakdown 2 2
Pocket Erosion 2 2
Bacterial Infection 2 2
No Information 2 2
Swelling/ Edema 2 2
No Patient Involvement 2 2
Eye Pain 1 1
Hemorrhage/Bleeding 1 1
Blurred Vision 1 1
Hydrocephalus 1 1
Abscess 1 1
Visual Impairment 1 1
Hair Loss 1 1
Fall 1 1
Numbness 1 1
Nerve Damage 1 1
Paralysis 1 1
Intracranial Hemorrhage 1 1
Cognitive Changes 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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