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TPLC
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Device
drills, burrs, trephines & accessories (simple, powered)
Product Code
HBE
Regulation Number
882.4310
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADEOR MEDICAL AG
SUBSTANTIALLY EQUIVALENT
1
AESCULAP INC.
SUBSTANTIALLY EQUIVALENT
1
AESCULAP, INC.
SUBSTANTIALLY EQUIVALENT
3
BIOMET MICOFIXATION
SUBSTANTIALLY EQUIVALENT
1
BIOMET MICROFIXATION
SUBSTANTIALLY EQUIVALENT
2
HUBLY INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC POWERED SURGICAL SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC SOFAMOR DANEK USA, INC.
SUBSTANTIALLY EQUIVALENT
1
NAKANISHI INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
2
THE ANSPACH EFFORT, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
787
6375
2019
836
8856
2020
1025
10801
2021
1047
10601
2022
900
7868
2023
392
3335
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
1887
11364
Fracture
1044
1198
Flaked
746
32993
Break
466
545
Vibration
243
243
Detachment of Device or Device Component
182
247
Excessive Heating
151
151
Material Fragmentation
109
111
Material Twisted/Bent
82
961
Noise, Audible
77
77
No Apparent Adverse Event
60
60
Physical Resistance/Sticking
45
45
Fluid/Blood Leak
40
50
Mechanical Problem
38
38
Mechanical Jam
35
35
Use of Device Problem
34
34
Separation Problem
33
33
Connection Problem
27
27
Device Remains Activated
25
25
Smoking
25
25
Electrical /Electronic Property Problem
21
21
Dull, Blunt
20
20
Material Separation
19
19
Defective Component
17
17
Material Deformation
17
22
Complete Loss of Power
14
14
Material Disintegration
14
17
Bent
13
91
Material Integrity Problem
12
12
Adverse Event Without Identified Device or Use Problem
11
11
Self-Activation or Keying
10
10
Display or Visual Feedback Problem
9
9
Delivered as Unsterile Product
9
9
Intermittent Loss of Power
9
9
Unintended Movement
9
9
Appropriate Term/Code Not Available
9
9
Packaging Problem
8
8
Difficult to Remove
8
8
Tear, Rip or Hole in Device Packaging
8
8
Device-Device Incompatibility
8
8
Entrapment of Device
7
7
Computer Software Problem
7
7
Insufficient Information
7
7
Device Operates Differently Than Expected
6
6
Mechanics Altered
6
6
Naturally Worn
6
6
Loss of Power
6
6
Expiration Date Error
6
6
Device Displays Incorrect Message
5
5
Unintended System Motion
5
5
Misconnection
5
5
Difficult to Insert
5
5
Intermittent Continuity
5
5
Disassembly
5
6
Fail-Safe Did Not Operate
5
5
Environmental Particulates
4
4
Output Problem
4
4
Corroded
4
54
Image Display Error/Artifact
4
4
Fitting Problem
4
4
Defective Device
4
4
Unstable
3
3
Leak/Splash
3
3
Failure to Power Up
3
3
Peeled/Delaminated
3
3
Degraded
3
3
Circuit Failure
3
3
Detachment Of Device Component
3
3
Power Problem
3
3
Premature Separation
3
3
Inadequate Lubrication
2
26
Operating System Becomes Nonfunctional
2
2
Output below Specifications
2
2
Fail-Safe Problem
2
2
Device Dislodged or Dislocated
2
2
Temperature Problem
2
2
Intermittent Communication Failure
2
2
Nonstandard Device
2
2
Device Emits Odor
2
2
Loose or Intermittent Connection
2
2
Device Slipped
2
2
Metal Shedding Debris
2
2
Improper or Incorrect Procedure or Method
2
2
Component Missing
2
2
Communication or Transmission Problem
2
2
Blocked Connection
2
2
Deformation Due to Compressive Stress
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Markings/Labelling Problem
1
1
Sparking
1
1
Misfire
1
1
Difficult or Delayed Activation
1
1
Failure to Calibrate
1
1
Failure to Align
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Inoperable
1
1
Inability to Irrigate
1
1
Imprecision
1
1
Material Frayed
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2542
28815
No Consequences Or Impact To Patient
1090
7599
No Patient Involvement
888
17407
No Known Impact Or Consequence To Patient
547
4313
Insufficient Information
57
1382
Device Embedded In Tissue or Plaque
56
56
Foreign Body In Patient
55
55
Burn(s)
41
567
Superficial (First Degree) Burn
24
376
No Information
24
134
Unintended Radiation Exposure
22
22
Injury
21
21
Perforation
18
18
Radiation Exposure, Unintended
12
12
Hemorrhage/Bleeding
11
11
Chemical Exposure
10
10
Burn, Thermal
6
107
Abrasion
5
5
Pain
5
5
Unspecified Tissue Injury
5
5
Paresis
4
4
Numbness
4
4
Spinal Cord Injury
4
4
Blood Loss
4
4
No Code Available
3
3
Swelling/ Edema
2
2
Partial thickness (Second Degree) Burn
2
7
Patient Problem/Medical Problem
2
2
Tissue Damage
2
2
Perforation of Vessels
1
1
Pulmonary Dysfunction
1
1
Coma
1
1
Brain Injury
1
1
Failure of Implant
1
1
Oversedation
1
1
Cerebrospinal Fluid Leakage
1
1
Contusion
1
1
Death
1
1
Erythema
1
1
Hematoma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ad-Tech Medical Instrument Corporation
II
Jul-25-2018
2
Aesculap Implant Systems LLC
II
Feb-15-2018
3
Medtronic Xomed, Inc.
II
Oct-21-2021
4
Stryker Instruments
II
Jul-28-2022
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