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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
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeBWN
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 16 16
2022 6 6
2023 50 50
2024 50 50
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 38 38
Unintended Movement 24 24
Insufficient Information 18 18
Break 17 17
Detachment of Device or Device Component 16 16
Material Split, Cut or Torn 8 8
Positioning Failure 8 8
Device Fell 7 7
Device Slipped 6 6
Component Missing 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Material Twisted/Bent 5 5
Patient Device Interaction Problem 5 5
Naturally Worn 4 4
Device Dislodged or Dislocated 4 4
Mechanical Problem 4 4
Fracture 3 3
Improper or Incorrect Procedure or Method 3 3
Difficult to Open or Close 3 3
Human-Device Interface Problem 2 2
Fitting Problem 2 2
Defective Device 2 2
Battery Problem 1 1
Solder Joint Fracture 1 1
Unstable 1 1
Loose or Intermittent Connection 1 1
Product Quality Problem 1 1
Component Falling 1 1
Contamination 1 1
Crack 1 1
Material Deformation 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Loss of or Failure to Bond 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75 75
Insufficient Information 14 14
Laceration(s) 13 13
Unspecified Tissue Injury 9 9
Bone Fracture(s) 6 6
Abrasion 5 5
No Information 4 4
Hematoma 4 4
Injury 4 4
Numbness 4 4
Pain 4 4
Limb Fracture 4 4
Ulcer 4 4
Head Injury 3 3
Fall 3 3
Bruise/Contusion 3 3
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
No Consequences Or Impact To Patient 2 2

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