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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
Regulation Description Cranioplasty plate fastener.
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
2020 1 1
2021 2 2
2022 2 2
2023 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 3 3
Device Appears to Trigger Rejection 2 2
Break 1 1
Patient-Device Incompatibility 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Unspecified Infection 2 2
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Failure of Implant 1 1
Foreign Body Reaction 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
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