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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 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 545 545
Device Remains Activated 305 305
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 153 153
Dull, Blunt 81 81
Mechanical Problem 73 73
Break 47 47
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 15 15
Insufficient Information 13 13
Failure to Cut 10 10
Fracture 10 10
Device Operates Differently Than Expected 9 9
Difficult to Remove 7 7
No Apparent Adverse Event 7 7
Material Fragmentation 7 7
Device Contamination with Chemical or Other Material 6 6
Peeled/Delaminated 6 6
Overheating of Device 6 6
Failure to Shut Off 6 6
Entrapment of Device 6 6
Activation Problem 6 6
Fail-Safe Problem 5 5
Device Operational Issue 5 5
Defective Device 5 5
Positioning Problem 4 4
Disconnection 4 4
Protective Measures Problem 4 4
Loss of Power 4 4
Material Integrity Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Metal Shedding Debris 3 3
Material Discolored 3 3
Device Issue 3 3
Mechanical Jam 3 3
Separation Failure 3 3
Unintended Movement 3 3
Physical Resistance/Sticking 3 3
Flaked 3 3
Separation Problem 2 2
Detachment of Device or Device Component 2 2
Premature Activation 2 2
Sticking 2 2
Vibration 2 2
Misconnection 2 2
Material Disintegration 2 2
Device Abrasion From Instrument Or Another Object 2 2
Particulates 2 2
Failure to Eject 2 2
Electrical /Electronic Property Problem 2 2
Connection Problem 1 1
Activation Failure 1 1
Delivered as Unsterile Product 1 1
Self-Activation or Keying 1 1
Failure to Deliver 1 1
Melted 1 1
Unintended Ejection 1 1
Device Dislodged or Dislocated 1 1
Communication or Transmission Problem 1 1
Failure to Sense 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Defective Component 1 1
Device Fell 1 1
Material Deformation 1 1
Detachment Of Device Component 1 1
Intermittent Loss of Power 1 1
Unsealed Device Packaging 1 1
Cut In Material 1 1
Device Slipped 1 1
Output Problem 1 1
Noise, Audible 1 1
No Device Output 1 1
Failure to Align 1 1
Split 1 1
Material Perforation 1 1
Failure to Disconnect 1 1
Loose or Intermittent Connection 1 1
Difficult to Advance 1 1
Material Erosion 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 294 294
Perforation 224 224
No Known Impact Or Consequence To Patient 173 173
Tissue Damage 141 141
No Information 135 135
Brain Injury 134 134
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 46 46
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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