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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device headrest, neurosurgical
Regulation Description Neurosurgical headrests.
Product CodeHBM
Regulation Number 882.4440
Device Class 1

MDR Year MDR Reports MDR Events
2021 10 10
2022 5 5
2023 8 8
2024 5 5
2025 5 5
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Use of Device Problem 4 4
Unstable 3 3
Unintended Movement 3 3
Device Slipped 2 2
Patient Device Interaction Problem 2 2
Mechanical Jam 2 2
Insufficient Device Problem Information 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Naturally Worn 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Pain 4 4
Spinal Cord Injury 3 3
Laceration(s) 3 3
Skin Inflammation/ Irritation 2 2
Insufficient Information 2 2
Pressure Sore/Ulcer 2 2
Numbness 1 1
Skull Fracture 1 1
Ulcer 1 1
Neck Stiffness 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Steris Corporation II Feb-05-2024
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