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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
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 136 136
2019 208 208
2020 324 324
2021 309 309
2022 148 148
2023 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 391 391
Device Remains Activated 285 285
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 140 140
Mechanical Problem 73 73
Break 27 27
Dull, Blunt 26 26
Fracture 10 10
Adverse Event Without Identified Device or Use Problem 8 8
Difficult to Remove 7 7
Material Fragmentation 6 6
Insufficient Information 6 6
Activation Problem 6 6
No Apparent Adverse Event 5 5
Defective Device 5 5
Material Separation 5 5
Use of Device Problem 5 5
Entrapment of Device 4 4
Overheating of Device 4 4
Failure to Shut Off 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 3 3
Material Integrity Problem 3 3
Physical Resistance/Sticking 3 3
Separation Failure 3 3
Failure to Cut 2 2
Detachment of Device or Device Component 2 2
Vibration 2 2
Particulates 2 2
Peeled/Delaminated 2 2
Loss of Power 2 2
Premature Activation 2 2
Material Disintegration 2 2
Electrical /Electronic Property Problem 2 2
Failure to Eject 2 2
Separation Problem 2 2
Mechanical Jam 2 2
Appropriate Term/Code Not Available 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
Loose or Intermittent Connection 1 1
Material Erosion 1 1
Unintended Ejection 1 1
Flaked 1 1
Melted 1 1
Misconnection 1 1
Delivered as Unsterile Product 1 1
Material Perforation 1 1
Defective Component 1 1
Device Slipped 1 1
Sticking 1 1
Self-Activation or Keying 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Failure to Align 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 256 256
Perforation 206 206
No Known Impact Or Consequence To Patient 147 147
Brain Injury 122 122
Tissue Damage 109 109
Injury 104 104
Abrasion 88 88
No Consequences Or Impact To Patient 86 86
Hemorrhage/Bleeding 50 50
Insufficient Information 37 37
No Information 26 26
Contusion 23 23
Unspecified Tissue Injury 11 11
Laceration(s) 10 10
No Patient Involvement 9 9
Foreign Body In Patient 7 7
Bruise/Contusion 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Rupture 5 5
Hematoma 4 4
Patient Problem/Medical Problem 4 4
No Code Available 4 4
Spinal Cord Injury 4 4
Chemical Exposure 3 3
Unintended Radiation Exposure 3 3
Blood Loss 2 2
Sinus Perforation 2 2
Cerebrospinal Fluid Leakage 2 2
Dysphasia 2 2
Perforation of Vessels 1 1
Skull Fracture 1 1
Therapeutic Effects, Unexpected 1 1
Stroke/CVA 1 1
Damage to Ligament(s) 1 1
Paralysis 1 1
Hemostasis 1 1
Coma 1 1
Ambulation Difficulties 1 1
Convulsion/Seizure 1 1
Speech Disorder 1 1
Vascular Dissection 1 1
Radiation Exposure, Unintended 1 1

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