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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
EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.
  SUBSTANTIALLY EQUIVALENT 1
EVONOS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 299 299
Device Remains Activated 285 285
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 153 153
Mechanical Problem 62 62
Break 42 42
Dull, Blunt 19 19
Material Separation 14 14
Fracture 7 7
No Apparent Adverse Event 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Activation Problem 6 6
Entrapment of Device 5 5
Difficult to Remove 5 5
Overheating of Device 5 5
Use of Device Problem 5 5
Defective Device 5 5
Insufficient Information 4 4
Failure to Shut Off 4 4
Material Integrity Problem 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Mechanical Jam 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Separation Failure 3 3
Loss of Power 3 3
Material Fragmentation 3 3
Material Disintegration 2 2
Electrical /Electronic Property Problem 2 2
Premature Activation 2 2
Particulates 2 2
Peeled/Delaminated 2 2
Misconnection 2 2
Failure to Cut 2 2
Detachment of Device or Device Component 2 2
Vibration 2 2
Separation Problem 2 2
Flaked 2 2
Failure to Eject 2 2
Unintended Movement 2 2
Material Deformation 1 1
Output Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Material Perforation 1 1
Defective Component 1 1
Device Slipped 1 1
Failure to Align 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Delivered as Unsterile Product 1 1
Self-Activation or Keying 1 1
Material Erosion 1 1
Unintended Ejection 1 1
Loose or Intermittent Connection 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 294 294
Perforation 204 204
No Known Impact Or Consequence To Patient 115 115
Brain Injury 113 113
Injury 104 104
Abrasion 72 72
No Consequences Or Impact To Patient 67 67
Tissue Damage 58 58
Hemorrhage/Bleeding 48 48
Insufficient Information 46 46
Contusion 21 21
No Information 21 21
Unspecified Tissue Injury 11 11
Laceration(s) 10 10
No Patient Involvement 9 9
Foreign Body In Patient 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Rupture 6 6
Bruise/Contusion 6 6
Spinal Cord Injury 4 4
Chemical Exposure 3 3
Patient Problem/Medical Problem 3 3
Hematoma 3 3
Unintended Radiation Exposure 3 3
No Code Available 2 2
Dysphasia 2 2
Sinus Perforation 2 2
Coma 1 1
Ambulation Difficulties 1 1
Convulsion/Seizure 1 1
Speech Disorder 1 1
Vascular Dissection 1 1
Radiation Exposure, Unintended 1 1
Hemostasis 1 1
Stroke/CVA 1 1
Cerebrospinal Fluid Leakage 1 1
Perforation of Vessels 1 1
Damage to Ligament(s) 1 1
Paralysis 1 1
Skull Fracture 1 1
Therapeutic Effects, Unexpected 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Nov-06-2020
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