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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drills, burrs, trephines & accessories (compound, powered)
Product CodeHBF
Regulation Number 882.4305
Device Class 2


Premarket Reviews
ManufacturerDecision
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 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 547 547
Device Remains Activated 312 312
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 158 158
Dull, Blunt 81 81
Mechanical Problem 73 73
Break 58 58
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 11 11
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
Detachment of Device or Device Component 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
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 316 316
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
Insufficient Information 53 53
No Code Available 52 52
Contusion 29 29
Laceration(s) 14 14
No Patient Involvement 11 11
Unspecified Tissue Injury 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 7 7
Bruise/Contusion 7 7
Rupture 7 7
Hematoma 6 6
Hemostasis 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
Convulsion/Seizure 2 2
Speech Disorder 1 1
Hydrocephalus 1 1
Vascular Dissection 1 1
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
Intracranial Hemorrhage 1 1
Scarring 1 1
Skull Fracture 1 1
Therapeutic Effects, Unexpected 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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