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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2019 6 6
2020 9 9
2021 16 16
2022 6 6
2023 50 50
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 38 38
Unintended Movement 22 22
Insufficient Information 20 20
Detachment of Device or Device Component 16 16
Break 13 13
Material Split, Cut or Torn 8 8
Mechanical Problem 8 8
Positioning Failure 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Device Fell 7 7
Device Slipped 6 6
Component Missing 6 6
Patient Device Interaction Problem 5 5
Material Twisted/Bent 4 4
Naturally Worn 4 4
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 2 2
Defective Device 2 2
Sharp Edges 2 2
Fracture 2 2
Device Dislodged or Dislocated 2 2
Human-Device Interface Problem 2 2
Unstable 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Positioning Problem 1 1
Contamination 1 1
Battery Problem 1 1
Structural Problem 1 1
Solder Joint Fracture 1 1
Material Deformation 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 70 70
Laceration(s) 16 16
Insufficient Information 13 13
Unspecified Tissue Injury 9 9
Injury 8 8
Bone Fracture(s) 6 6
Abrasion 5 5
No Information 4 4
Hematoma 4 4
Numbness 4 4
Pain 4 4
Limb Fracture 4 4
Ulcer 4 4
Fall 3 3
No Consequences Or Impact To Patient 3 3
Head Injury 2 2
Muscle Weakness 2 2
Tooth Fracture 2 2
No Known Impact Or Consequence To Patient 2 2
Nerve Damage 2 2
Skin Tears 2 2
Bruise/Contusion 2 2
Hair Loss 1 1
Headache 1 1

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