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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

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Unintended Movement 7 7
Device Slipped 7 7
Loose or Intermittent Connection 6 6
Break 4 4
Use of Device Problem 4 4
Patient Device Interaction Problem 3 3
Mechanical Jam 2 2
Naturally Worn 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Failure To Adhere Or Bond 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 12 12
No Clinical Signs, Symptoms or Conditions 11 11
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
No Patient Involvement 1 1
Contusion 1 1
Hypersensitivity/Allergic reaction 1 1
Full thickness (Third Degree) Burn 1 1
Local Reaction 1 1
Skull Fracture 1 1
Tissue Damage 1 1
Ulcer 1 1
Numbness 1 1
Spinal Cord Injury 1 1
Skin Inflammation 1 1

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