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TPLC
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Device
headrest, neurosurgical
Regulation Description
Neurosurgical headrests.
Product Code
HBM
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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