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TPLC
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Device
motor, drill, electric
Regulation Description
Electric cranial drill motor.
Product Code
HBC
Regulation Number
882.4360
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIEN-AIR SURGERY SA
SUBSTANTIALLY EQUIVALENT
1
SAESHIN PRECISION CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
THE ANSPACH EFFORT, INC.
SUBSTANTIALLY EQUIVALENT
1
ZETHON LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
1304
1304
2021
946
946
2022
760
760
2023
664
664
2024
427
427
2025
270
270
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
1924
1924
Vibration
602
602
Overheating of Device
478
478
Device Damaged by Another Device
438
438
Detachment of Device or Device Component
301
301
Complete Loss of Power
264
264
Unintended System Motion
253
253
Device Alarm System
203
203
Noise, Audible
187
187
Break
165
165
Device-Device Incompatibility
151
151
Fail-Safe Did Not Operate
129
129
Appropriate Term/Code Not Available
114
114
Material Fragmentation
110
110
Mechanical Jam
59
59
Material Frayed
49
49
Separation Problem
46
46
Leak/Splash
41
41
Output below Specifications
38
38
Difficult or Delayed Separation
35
35
Fail-Safe Problem
34
34
Premature Separation
31
31
No Apparent Adverse Event
26
26
Device Slipped
24
24
Mechanical Problem
23
23
Loss of Power
18
18
Environmental Particulates
16
16
Electrical /Electronic Property Problem
14
14
Corroded
14
14
Device Reprocessing Problem
14
14
Difficult to Insert
12
12
Fluid/Blood Leak
11
11
Component Missing
10
10
Intermittent Loss of Power
8
8
Adverse Event Without Identified Device or Use Problem
8
8
Device Remains Activated
7
7
Dull, Blunt
7
7
Physical Resistance/Sticking
7
7
Device Markings/Labelling Problem
7
7
Difficult to Remove
6
6
Device Displays Incorrect Message
6
6
Naturally Worn
6
6
Connection Problem
6
6
Unintended Movement
6
6
Material Integrity Problem
5
5
Separation Failure
5
5
Power Problem
5
5
Fracture
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Material Deformation
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3166
3166
No Consequences Or Impact To Patient
1114
1114
No Known Impact Or Consequence To Patient
44
44
Insufficient Information
26
26
Burn(s)
13
13
Unspecified Tissue Injury
5
5
Brain Injury
3
3
Burn, Thermal
3
3
Full thickness (Third Degree) Burn
3
3
Superficial (First Degree) Burn
2
2
Perforation
2
2
Injury
2
2
Foreign Body In Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Chemical Exposure
1
1
Post Traumatic Wound Infection
1
1
Peroneal Nerve Palsy
1
1
Aneurysm
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
The Anspach Effort, Inc.
II
Jan-07-2023
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