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TPLC
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Device
drills, burrs, trephines & accessories (compound, powered)
Product Code
HBF
Regulation Number
882.4305
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADEOR MEDICAL TECHNOLOGIES GMBH
SUBSTANTIALLY EQUIVALENT
1
EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.
SUBSTANTIALLY EQUIVALENT
1
EVONOS GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
INTEGRA LIFESCIENCES CORP.
SUBSTANTIALLY EQUIVALENT
1
MICROMAR IND. COM. LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
95
95
2015
59
59
2016
76
76
2017
106
106
2018
136
136
2019
208
208
2020
324
324
2021
309
309
2022
148
148
2023
108
108
2024
66
66
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Auto Stop
545
545
Device Remains Activated
308
308
Activation, Positioning or Separation Problem
166
166
Fail-Safe Did Not Operate
157
157
Dull, Blunt
81
81
Mechanical Problem
73
73
Break
52
52
Adverse Event Without Identified Device or Use Problem
33
33
Appropriate Term/Code Not Available
31
31
Use of Device Problem
26
26
Plunge
19
19
Material Separation
16
16
Insufficient Information
14
14
Fracture
10
10
Failure to Cut
10
10
Device Operates Differently Than Expected
9
9
No Apparent Adverse Event
8
8
Material Fragmentation
7
7
Difficult to Remove
7
7
Peeled/Delaminated
6
6
Overheating of Device
6
6
Entrapment of Device
6
6
Failure to Shut Off
6
6
Device Contamination with Chemical or Other Material
6
6
Activation Problem
6
6
Device Operational Issue
5
5
Fail-Safe Problem
5
5
Defective Device
5
5
Material Integrity Problem
4
4
Positioning Problem
4
4
Protective Measures Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Disconnection
4
4
Loss of Power
4
4
Material Disintegration
3
3
Material Discolored
3
3
Flaked
3
3
Unintended Movement
3
3
Mechanical Jam
3
3
Separation Failure
3
3
Device Issue
3
3
Metal Shedding Debris
3
3
Separation Problem
3
3
Physical Resistance/Sticking
3
3
Failure to Eject
2
2
Sticking
2
2
Detachment of Device or Device Component
2
2
Device Abrasion From Instrument Or Another Object
2
2
Misconnection
2
2
Electrical /Electronic Property Problem
2
2
Premature Activation
2
2
Particulates
2
2
Vibration
2
2
Device Slipped
1
1
Self-Activation or Keying
1
1
Failure to Sense
1
1
Unsealed Device Packaging
1
1
Melted
1
1
Material Erosion
1
1
Unintended Ejection
1
1
Detachment Of Device Component
1
1
Crack
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Delivered as Unsterile Product
1
1
No Device Output
1
1
Loose or Intermittent Connection
1
1
Communication or Transmission Problem
1
1
Connection Problem
1
1
Material Perforation
1
1
Defective Component
1
1
Failure to Deliver
1
1
Cut In Material
1
1
Failure to Align
1
1
Split
1
1
Failure to Disconnect
1
1
Mechanics Altered
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Device Fell
1
1
Intermittent Loss of Power
1
1
Activation Failure
1
1
Noise, Audible
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
306
306
Perforation
225
225
No Known Impact Or Consequence To Patient
173
173
Tissue Damage
141
141
Brain Injury
135
135
No Information
135
135
No Consequences Or Impact To Patient
132
132
Abrasion
118
118
Injury
111
111
Hemorrhage/Bleeding
56
56
No Code Available
52
52
Insufficient Information
51
51
Contusion
29
29
Laceration(s)
14
14
Unspecified Tissue Injury
11
11
No Patient Involvement
11
11
Foreign Body In Patient
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Bruise/Contusion
6
6
Rupture
6
6
Hemostasis
5
5
Hematoma
5
5
Sinus Perforation
4
4
Spinal Cord Injury
4
4
Patient Problem/Medical Problem
4
4
Unintended Radiation Exposure
3
3
Radiation Exposure, Unintended
3
3
Chemical Exposure
3
3
Blood Loss
3
3
Cerebrospinal Fluid Leakage
3
3
Burn(s)
2
2
Dysphasia
2
2
Internal Organ Perforation
2
2
Pain
1
1
Paralysis
1
1
Perforation of Vessels
1
1
Blurred Vision
1
1
Ambulation Difficulties
1
1
Physical Entrapment
1
1
Coma
1
1
Stroke/CVA
1
1
Death
1
1
Bone Fracture(s)
1
1
Damage to Ligament(s)
1
1
Hemorrhage, Cerebral
1
1
Scarring
1
1
Skull Fracture
1
1
Therapeutic Effects, Unexpected
1
1
Vascular Dissection
1
1
Hydrocephalus
1
1
Convulsion/Seizure
1
1
Speech Disorder
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet Microfixation, Inc.
II
Jan-11-2012
2
Stryker Instruments Div. of Stryker Corporation
II
Nov-06-2020
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