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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fastener, plate, cranioplasty
Product CodeHBW
Regulation Number 882.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 20 20
2020 1 1
2021 2 2
2022 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16 16
Fracture 9 9
Device Slipped 8 8
Detachment of Device or Device Component 6 6
Break 3 3
Device Handling Problem 2 2
Difficult to Insert 2 2
Device Appears to Trigger Rejection 1 1
Use of Device Problem 1 1
Deformation Due to Compressive Stress 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 14 14
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 5 5
Foreign Body In Patient 4 4
Impaired Healing 3 3
Cerebrospinal Fluid Leakage 2 2
No Clinical Signs, Symptoms or Conditions 2 2
No Information 2 2
No Code Available 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Visual Impairment 1 1
Bacterial Infection 1 1
Brain Injury 1 1

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