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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
2018 1 1
2019 6 6
2020 9 9
2021 16 16
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 12 12
Mechanical Problem 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Material Split, Cut or Torn 6 6
Use of Device Problem 5 5
Detachment of Device or Device Component 4 4
Unintended Movement 3 3
Human-Device Interface Problem 2 2
Break 2 2
Component Falling 1 1
Positioning Failure 1 1
Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Structural Problem 1 1
Device Slipped 1 1
Unstable 1 1
Mechanical Jam 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Positioning Problem 1 1
Sharp Edges 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Unspecified Tissue Injury 8 8
Injury 8 8
Insufficient Information 6 6
No Information 4 4
Numbness 4 4
Bone Fracture(s) 4 4
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Fall 2 2
No Known Impact Or Consequence To Patient 2 2
Muscle Weakness 2 2
Nerve Damage 2 2
Pain 1 1
Hair Loss 1 1
Head Injury 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Innovative Orthopedic Technologies, LLC II Oct-07-2021
2 The Anspach Effort, Inc. II May-04-2017
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