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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 66 66

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 299 299
Device Remains Activated 288 288
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 157 157
Mechanical Problem 62 62
Break 47 47
Dull, Blunt 19 19
Material Separation 15 15
No Apparent Adverse Event 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Fracture 7 7
Activation Problem 6 6
Defective Device 5 5
Insufficient Information 5 5
Entrapment of Device 5 5
Overheating of Device 5 5
Difficult to Remove 5 5
Use of Device Problem 5 5
Positioning Problem 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Shut Off 4 4
Material Integrity Problem 4 4
Mechanical Jam 3 3
Appropriate Term/Code Not Available 3 3
Separation Problem 3 3
Physical Resistance/Sticking 3 3
Separation Failure 3 3
Loss of Power 3 3
Material Fragmentation 3 3
Material Disintegration 3 3
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
Flaked 2 2
Failure to Eject 2 2
Unintended Movement 2 2
Activation Failure 1 1
Noise, Audible 1 1
Output Problem 1 1
Material Deformation 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Material Perforation 1 1
Defective Component 1 1
Self-Activation or Keying 1 1
Device Slipped 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Failure to Align 1 1
Delivered as Unsterile Product 1 1
Melted 1 1
Crack 1 1
Loose or Intermittent Connection 1 1
Material Erosion 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 306 306
Perforation 205 205
No Known Impact Or Consequence To Patient 115 115
Brain Injury 114 114
Injury 104 104
Abrasion 72 72
No Consequences Or Impact To Patient 67 67
Tissue Damage 58 58
Insufficient Information 51 51
Hemorrhage/Bleeding 48 48
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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