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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
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FIN-CERAMICA FAENZA S.P.A.
  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 3
MEDCAD
  SUBSTANTIALLY EQUIVALENT 1
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 63 63
2022 57 57
2023 32 32
2024 35 36
2025 24 24
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 131 131
Defective Device 44 44
Break 8 8
Insufficient Information 7 7
Appropriate Term/Code Not Available 4 4
Migration 3 4
Inadequacy of Device Shape and/or Size 2 2
Difficult or Delayed Positioning 2 2
Tear, Rip or Hole in Device Packaging 2 2
No Apparent Adverse Event 2 2
Difficult to Open or Remove Packaging Material 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Loss of Osseointegration 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Positioning Failure 1 1
Material Erosion 1 2
Fracture 1 1
Melted 1 1
Nonstandard Device 1 1
Product Quality Problem 1 1
Fitting Problem 1 1
Defective Component 1 1
Crack 1 1
Decoupling 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 85 85
No Clinical Signs, Symptoms or Conditions 56 56
Insufficient Information 24 24
Post Operative Wound Infection 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Hematoma 4 4
Unspecified Tissue Injury 4 4
Cerebrospinal Fluid Leakage 4 4
Pain 3 4
Non-union Bone Fracture 3 3
Impaired Healing 2 2
Wound Dehiscence 2 2
Failure of Implant 2 2
Post Traumatic Wound Infection 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Swelling/ Edema 2 2
Tissue Breakdown 2 2
Skin Infection 1 1
Dry Mouth 1 2
Drug Resistant Bacterial Infection 1 1
Hemolysis 1 1
Metal Related Pathology 1 2
Cognitive Changes 1 1
Paralysis 1 1
Nerve Damage 1 1
Numbness 1 1
Fall 1 1
Hair Loss 1 1
Abscess 1 1
Hydrocephalus 1 1
Blurred Vision 1 1
Skin Tears 1 1
Bacterial Infection 1 1
Eye Pain 1 2

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