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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
2020 17 17
2021 10 10
2022 5 5
2023 8 8
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Mechanical Problem 9 9
Device Slipped 6 6
Loose or Intermittent Connection 4 4
Use of Device Problem 4 4
Unintended Movement 3 3
Mechanical Jam 2 2
Patient Device Interaction Problem 2 2
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Difficult to Open or Close 1 1
Unstable 1 1
Insufficient Information 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
Laceration(s) 7 7
No Known Impact Or Consequence To Patient 7 7
Spinal Cord Injury 3 3
Pain 3 3
Skin Inflammation/ Irritation 2 2
Pressure Sores 2 2
Skin Tears 2 2
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
Hypersensitivity/Allergic reaction 1 1
Skull Fracture 1 1
Ulcer 1 1
Full thickness (Third Degree) Burn 1 1
Numbness 1 1

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