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TPLC
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show TPLC since
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2023
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Device
motor, drill, electric
Product Code
HBC
Regulation Number
882.4360
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIEN-AIR SURGERY SA
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC POWERED SURGICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
THE ANSPACH EFFORT, INC.
SUBSTANTIALLY EQUIVALENT
1
ZETHON LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1779
1779
2019
1703
1703
2020
1304
1304
2021
946
946
2022
761
761
2023
292
292
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
1764
1764
Overheating of Device
1696
1696
Vibration
1228
1228
Unintended System Motion
573
573
Detachment of Device or Device Component
476
476
Device Damaged by Another Device
343
343
Material Twisted/Bent
309
309
Device Alarm System
263
263
Complete Loss of Power
196
196
Noise, Audible
160
160
Break
131
131
Device-Device Incompatibility
119
119
Fail-Safe Did Not Operate
117
117
Fail-Safe Problem
106
106
Material Fragmentation
96
96
Bent
84
84
Detachment Of Device Component
73
73
Appropriate Term/Code Not Available
72
72
Fracture
71
71
Mechanical Jam
52
52
Material Frayed
44
44
Output below Specifications
43
43
Leak/Splash
40
40
Device Displays Incorrect Message
38
38
Fluid/Blood Leak
37
37
Mechanical Problem
35
35
Device Operates Differently Than Expected
32
32
Separation Problem
31
31
Premature Separation
24
24
Difficult or Delayed Separation
19
19
Device Slipped
19
19
Difficult To Position
18
18
Device Reprocessing Problem
14
14
Device Inoperable
14
14
Cut In Material
11
11
Component Missing
10
10
Material Separation
10
10
Material Rupture
10
10
Environmental Particulates
10
10
Adverse Event Without Identified Device or Use Problem
9
9
Unintended Movement
9
9
Device Operational Issue
9
9
Connection Problem
8
8
Difficult to Remove
8
8
Electrical /Electronic Property Problem
8
8
Intermittent Loss of Power
8
8
Material Deformation
8
8
No Apparent Adverse Event
7
7
Dull, Blunt
7
7
Device Markings/Labelling Problem
6
6
Image Display Error/Artifact
6
6
Device Remains Activated
5
5
Physical Resistance/Sticking
5
5
Naturally Worn
5
5
Smoking
4
4
Separation Failure
4
4
Difficult to Insert
4
4
Corroded
4
4
Defective Device
3
3
Contamination /Decontamination Problem
3
3
Component or Accessory Incompatibility
3
3
Retraction Problem
3
3
Self-Activation or Keying
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Power Problem
3
3
Device Fell
3
3
Intermittent Energy Output
2
2
Mechanics Altered
2
2
Moisture or Humidity Problem
2
2
Device Stops Intermittently
2
2
Metal Shedding Debris
2
2
Defective Component
2
2
Degraded
2
2
Display or Visual Feedback Problem
2
2
Disconnection
2
2
Misconnection
2
2
Loose or Intermittent Connection
2
2
Loss of Power
1
1
Energy Output Problem
1
1
Output above Specifications
1
1
Energy Spectrum Incorrect
1
1
Material Disintegration
1
1
Positioning Failure
1
1
Crack
1
1
Intermittent Continuity
1
1
Circuit Failure
1
1
Air Leak
1
1
False Alarm
1
1
Defective Alarm
1
1
Difficult to Open or Remove Packaging Material
1
1
Application Program Problem
1
1
Structural Problem
1
1
Dent in Material
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Unstable
1
1
Use of Device Problem
1
1
Excessive Cooling
1
1
Failure to Auto Stop
1
1
Protective Measures Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
3484
3484
No Clinical Signs, Symptoms or Conditions
2120
2120
No Known Impact Or Consequence To Patient
1091
1091
No Patient Involvement
24
24
Insufficient Information
18
18
Burn(s)
13
13
Foreign Body In Patient
13
13
Patient Problem/Medical Problem
12
12
Brain Injury
9
9
Nervous System Injury
8
8
Death
5
5
Burn, Thermal
5
5
Tissue Damage
4
4
Not Applicable
4
4
No Code Available
3
3
Injury
3
3
Blood Loss
2
2
Perforation
2
2
Unspecified Tissue Injury
2
2
Full thickness (Third Degree) Burn
2
2
Failure of Implant
2
2
Superficial (First Degree) Burn
2
2
Skull Fracture
1
1
Chemical Exposure
1
1
Aneurysm
1
1
Device Embedded In Tissue or Plaque
1
1
Peroneal Nerve Palsy
1
1
Post Traumatic Wound Infection
1
1
No Information
1
1
Hemorrhage/Bleeding
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
The Anspach Effort, Inc.
II
Jan-07-2023
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