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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2015 1 1
2016 2 2
2017 2 2
2018 2 2
2019 10 10
2020 17 17
2021 10 10
2022 5 5
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11 11
Adverse Event Without Identified Device or Use Problem 8 8
Device Slipped 7 7
Unintended Movement 7 7
Loose or Intermittent Connection 6 6
Use of Device Problem 4 4
Break 4 4
Patient Device Interaction Problem 3 3
Mechanical Jam 2 2
Unstable 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Difficult to Open or Close 1 1
Failure To Adhere Or Bond 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
No Consequences Or Impact To Patient 12 12
No Known Impact Or Consequence To Patient 9 9
Laceration(s) 8 8
Pain 3 3
Skin Inflammation/ Irritation 2 2
Insufficient Information 2 2
Skin Tears 2 2
Hypersensitivity/Allergic reaction 1 1
Skull Fracture 1 1
Local Reaction 1 1
Contusion 1 1
No Patient Involvement 1 1
Skin Inflammation 1 1
Numbness 1 1
Tissue Damage 1 1
Ulcer 1 1
Full thickness (Third Degree) Burn 1 1
Spinal Cord Injury 1 1

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