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TPLC
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show TPLC since
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Device
table and attachments, operating-room
Product Code
BWN
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
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