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TPLC
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show TPLC since
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2024
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Device
bur, surgical, general & plastic surgery
Product Code
GFF
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
80
80
2020
23
23
2021
76
76
2022
68
68
2023
96
101
2024
27
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
126
126
Material Fragmentation
80
80
Fracture
49
58
Failure to Cut
26
26
Detachment of Device or Device Component
18
18
Material Twisted/Bent
16
16
Overheating of Device
16
16
Defective Device
11
11
Entrapment of Device
9
9
Excessive Heating
8
8
Melted
5
5
Vibration
5
5
Device-Device Incompatibility
4
4
Material Separation
4
4
Material Integrity Problem
4
4
Adverse Event Without Identified Device or Use Problem
3
3
Device Contaminated During Manufacture or Shipping
3
3
Loose or Intermittent Connection
2
2
Unintended Collision
2
2
Flaked
2
2
Output Problem
2
2
Temperature Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Unintended Movement
2
2
Appropriate Term/Code Not Available
1
1
Explosion
1
1
Physical Resistance/Sticking
1
1
Packaging Problem
1
1
Scratched Material
1
1
Separation Problem
1
1
Loss of or Failure to Bond
1
1
Unintended Ejection
1
1
Thermal Decomposition of Device
1
1
Degraded
1
1
Material Disintegration
1
1
Peeled/Delaminated
1
1
Device Difficult to Setup or Prepare
1
1
Device Emits Odor
1
1
Material Deformation
1
1
Electro-Static Discharge
1
1
Defective Component
1
1
Mechanics Altered
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Device Slipped
1
1
Smoking
1
1
Unstable
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
206
215
No Consequences Or Impact To Patient
52
52
Insufficient Information
41
46
Foreign Body In Patient
31
31
Device Embedded In Tissue or Plaque
19
19
No Known Impact Or Consequence To Patient
16
16
Burn, Thermal
5
5
Burn(s)
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Failure of Implant
2
2
No Patient Involvement
2
2
Superficial (First Degree) Burn
1
1
Shock
1
1
Sinus Perforation
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Apr-23-2019
2
Brasseler USA I Lp
II
Dec-02-2019
3
In2Bones, SAS
II
Mar-19-2021
4
Wright Medical Technology, Inc.
II
Nov-25-2019
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