Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device headrest, neurosurgical
Product CodeHBM
Regulation Number 882.4440
Device Class 1

MDR Year MDR Reports MDR Events
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 7 7
Unintended Movement 7 7
Device Slipped 6 6
Loose or Intermittent Connection 6 6
Use of Device Problem 4 4
Patient Device Interaction Problem 2 2
Mechanical Jam 2 2
Break 2 2
Unstable 1 1
Naturally Worn 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Difficult to Open or Close 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 11 11
No Known Impact Or Consequence To Patient 7 7
Laceration(s) 7 7
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
Numbness 1 1
Skin Inflammation 1 1
Ulcer 1 1
Spinal Cord Injury 1 1
Full thickness (Third Degree) Burn 1 1

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