• 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 table and attachments, operating-room
Product CodeBWN
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 6 6
2020 9 9
2021 16 16
2022 6 6
2023 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 21 21
Insufficient Information 14 14
Unintended Movement 12 12
Detachment of Device or Device Component 11 11
Mechanical Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Material Split, Cut or Torn 7 7
Device Fell 7 7
Break 4 4
Positioning Failure 2 2
Device Slipped 2 2
Device Dislodged or Dislocated 2 2
Human-Device Interface Problem 2 2
Material Twisted/Bent 2 2
Sharp Edges 2 2
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Mechanical Jam 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 1 1
Fracture 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
Insufficient Information 11 11
Unspecified Tissue Injury 8 8
Laceration(s) 8 8
Injury 8 8
Bone Fracture(s) 5 5
Numbness 4 4
No Information 4 4
Fall 3 3
No Consequences Or Impact To Patient 3 3
Muscle Weakness 2 2
Nerve Damage 2 2
Pain 2 2
Limb Fracture 2 2
Head Injury 2 2
Skin Tears 2 2
No Known Impact Or Consequence To Patient 2 2
Headache 1 1
Abrasion 1 1
Hair Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Innovative Orthopedic Technologies, LLC II Oct-07-2021
-
-