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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
2017 106 106
2018 136 136
2019 208 208
2020 324 324
2021 309 309
2022 128 128

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Auto Stop 442 442
Device Remains Activated 279 279
Activation, Positioning or Separation Problem 166 166
Fail-Safe Did Not Operate 85 85
Mechanical Problem 68 68
Dull, Blunt 32 32
Break 26 26
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 7 7
Fracture 7 7
Difficult to Remove 7 7
Material Fragmentation 6 6
Activation Problem 6 6
No Apparent Adverse Event 5 5
Failure to Shut Off 5 5
Use of Device Problem 5 5
Defective Device 5 5
Material Separation 4 4
Entrapment of Device 4 4
Peeled/Delaminated 4 4
Positioning Problem 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Operational Issue 3 3
Physical Resistance/Sticking 3 3
Overheating of Device 3 3
Metal Shedding Debris 3 3
Separation Failure 3 3
Failure to Cut 2 2
Detachment of Device or Device Component 2 2
Vibration 2 2
Plunge 2 2
Material Disintegration 2 2
Separation Problem 2 2
Failure to Eject 2 2
Material Integrity Problem 2 2
Mechanical Jam 2 2
Unintended Movement 2 2
Appropriate Term/Code Not Available 2 2
Activation Failure 1 1
Noise, Audible 1 1
Device Dislodged or Dislocated 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Output Problem 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Electrical /Electronic Property Problem 1 1
Detachment Of Device Component 1 1
Material Erosion 1 1
Unintended Ejection 1 1
Loose or Intermittent Connection 1 1
Loss of Power 1 1
Premature Activation 1 1
Particulates 1 1
Melted 1 1
Misconnection 1 1
Material Perforation 1 1
Device Slipped 1 1
Sticking 1 1
Self-Activation or Keying 1 1
Device Operates Differently Than Expected 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Failure to Align 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 209 209
No Clinical Signs, Symptoms or Conditions 209 209
No Known Impact Or Consequence To Patient 151 151
Tissue Damage 135 135
Injury 104 104
No Consequences Or Impact To Patient 102 102
Brain Injury 96 96
Abrasion 92 92
No Information 64 64
Hemorrhage/Bleeding 45 45
Contusion 25 25
Insufficient Information 24 24
No Patient Involvement 9 9
Laceration(s) 8 8
Unspecified Tissue Injury 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Bruise/Contusion 6 6
Hematoma 4 4
Patient Problem/Medical Problem 4 4
Hemostasis 4 4
No Code Available 4 4
Unintended Radiation Exposure 3 3
Sinus Perforation 3 3
Foreign Body In Patient 3 3
Chemical Exposure 3 3
Cerebrospinal Fluid Leakage 3 3
Blood Loss 2 2
Radiation Exposure, Unintended 2 2
Dysphasia 2 2
Spinal Cord Injury 1 1
Physical Entrapment 1 1
Vascular Dissection 1 1
Hemorrhage, Cerebral 1 1
Stroke/CVA 1 1
Bone Fracture(s) 1 1
Damage to Ligament(s) 1 1
Internal Organ Perforation 1 1
Pain 1 1
Paralysis 1 1
Perforation of Vessels 1 1
Blurred Vision 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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