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TPLC
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2024
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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
1
MEDTRONIC POWERED SURGICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
1. K183515
MR8 Drill System, Midas Rex MR8 ClearView Tools
THE ANSPACH EFFORT, INC.
SUBSTANTIALLY EQUIVALENT
1
ZETHON LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1703
1703
2020
1304
1304
2021
946
946
2022
760
760
2023
664
664
2024
59
59
Device Problems
MDRs with this Device Problem
Events in those MDRs
Excessive Heating
1983
1983
Vibration
953
953
Overheating of Device
823
823
Unintended System Motion
427
427
Device Damaged by Another Device
420
420
Detachment of Device or Device Component
412
412
Device Alarm System
276
276
Complete Loss of Power
250
250
Noise, Audible
169
169
Material Twisted/Bent
156
156
Break
147
147
Device-Device Incompatibility
135
135
Fail-Safe Did Not Operate
129
129
Material Fragmentation
108
108
Appropriate Term/Code Not Available
92
92
Mechanical Jam
56
56
Material Frayed
47
47
Leak/Splash
42
42
Separation Problem
41
41
Output below Specifications
39
39
Fail-Safe Problem
33
33
Fracture
31
31
Premature Separation
30
30
Difficult or Delayed Separation
26
26
Mechanical Problem
23
23
Device Slipped
23
23
Fluid/Blood Leak
22
22
Device Reprocessing Problem
15
15
Environmental Particulates
14
14
No Apparent Adverse Event
11
11
Unintended Movement
9
9
Component Missing
9
9
Adverse Event Without Identified Device or Use Problem
9
9
Electrical /Electronic Property Problem
9
9
Intermittent Loss of Power
8
8
Dull, Blunt
7
7
Device Markings/Labelling Problem
7
7
Connection Problem
6
6
Separation Failure
5
5
Physical Resistance/Sticking
5
5
Manufacturing, Packaging or Shipping Problem
4
4
Corroded
4
4
Device Remains Activated
4
4
Material Rupture
4
4
Self-Activation or Keying
3
3
Retraction Problem
3
3
Naturally Worn
3
3
Power Problem
3
3
Contamination /Decontamination Problem
3
3
Component or Accessory Incompatibility
3
3
Device Fell
3
3
Intermittent Energy Output
2
2
Device Displays Incorrect Message
2
2
Mechanics Altered
2
2
Material Deformation
2
2
Loss of Power
2
2
Display or Visual Feedback Problem
2
2
Degraded
2
2
Misconnection
2
2
Positioning Failure
1
1
Energy Spectrum Incorrect
1
1
Crack
1
1
Intermittent Continuity
1
1
Circuit Failure
1
1
False Alarm
1
1
Defective Alarm
1
1
Energy Output Problem
1
1
Output above Specifications
1
1
Product Quality Problem
1
1
Material Separation
1
1
Device Damaged Prior to Use
1
1
Smoking
1
1
Unstable
1
1
Use of Device Problem
1
1
Failure to Auto Stop
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Component Misassembled
1
1
Material Too Soft/Flexible
1
1
Failure to Eject
1
1
Application Program Problem
1
1
Defective Device
1
1
Structural Problem
1
1
Excessive Cooling
1
1
Difficult to Open or Remove Packaging Material
1
1
Incomplete or Inadequate Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2542
2542
No Consequences Or Impact To Patient
2298
2298
No Known Impact Or Consequence To Patient
548
548
Insufficient Information
18
18
Burn(s)
11
11
Foreign Body In Patient
6
6
Unspecified Tissue Injury
5
5
Full thickness (Third Degree) Burn
3
3
Tissue Damage
3
3
Burn, Thermal
3
3
Failure of Implant
2
2
Perforation
2
2
Brain Injury
2
2
Injury
2
2
Superficial (First Degree) Burn
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Unintended Radiation Exposure
1
1
Patient Problem/Medical Problem
1
1
Peroneal Nerve Palsy
1
1
Post Traumatic Wound Infection
1
1
Hemorrhage/Bleeding
1
1
Chemical Exposure
1
1
No Patient Involvement
1
1
Aneurysm
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
The Anspach Effort, Inc.
II
Jan-07-2023
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