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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device motor, drill, pneumatic
Product CodeHBB
Regulation Number 882.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC POWERED SURGICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 562 562
2015 440 440
2016 273 452
2017 203 477
2018 295 652
2019 284 722
2020 263 372
2021 260 419
2022 172 332
2023 180 306
2024 56 102

Device Problems MDRs with this Device Problem Events in those MDRs
Output below Specifications 459 459
Bent 398 398
Overheating of Device 326 803
Leak/Splash 231 1060
Material Puncture/Hole 166 166
Device Operates Differently Than Expected 145 145
Break 136 134
Detachment of Device or Device Component 135 175
Noise, Audible 132 132
Fluid/Blood Leak 126 526
Unintended System Motion 114 114
Device Abrasion From Instrument Or Another Object 105 105
Device Inoperable 86 86
Fail-Safe Problem 81 100
No Apparent Adverse Event 75 75
Unintended Power Up 66 126
Air Leak 49 49
Vibration 43 43
Device Remains Activated 41 42
Hole In Material 35 35
Material Twisted/Bent 35 38
Naturally Worn 34 34
Burst Container or Vessel 34 48
Mechanical Jam 33 33
Excessive Heating 31 31
Complete Loss of Power 30 30
Physical Resistance/Sticking 28 29
Power Problem 28 28
Mechanical Problem 27 27
Fracture 25 25
Loss of Power 25 25
Sticking 23 25
Disassembly 22 31
Electrical /Electronic Property Problem 21 21
Partial Blockage 20 20
Detachment Of Device Component 15 15
Material Rupture 15 15
Self-Activation or Keying 15 15
Failure to Power Up 14 14
Appropriate Term/Code Not Available 14 14
Insufficient Information 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Failure to Shut Off 12 12
Temperature Problem 12 12
Difficult to Insert 12 12
Device Maintenance Issue 12 12
Difficult to Remove 11 11
Device Slipped 10 10
Defective Component 10 10
Unintended Movement 10 18
Defective Device 8 8
Misconnection 8 8
Cut In Material 7 7
Loose or Intermittent Connection 7 7
Material Fragmentation 7 7
Unexpected Shutdown 7 7
Device Damaged by Another Device 7 7
Material Deformation 6 6
Fitting Problem 6 6
Device Stops Intermittently 6 6
Pressure Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Premature Separation 5 5
Intermittent Loss of Power 4 4
Gas/Air Leak 4 4
Device-Device Incompatibility 4 4
Connection Problem 4 4
Failure to Auto Stop 4 4
Smoking 4 4
Energy Output Problem 4 4
Power Conditioning Problem 4 4
Material Separation 3 3
Incorrect Or Inadequate Test Results 3 3
Component Missing 3 3
Degraded 3 3
Migration or Expulsion of Device 3 5
Corroded 3 3
Failure of Device to Self-Test 3 3
Protective Measures Problem 3 3
Physical Resistance 3 3
Device Fell 3 3
Torn Material 3 3
Positioning Problem 3 3
Fail-Safe Did Not Operate 3 3
Device Operational Issue 2 2
Malposition of Device 2 2
Material Integrity Problem 2 2
Material Discolored 2 2
Entrapment of Device 2 2
Dull, Blunt 2 2
Obstruction of Flow 2 2
Metal Shedding Debris 2 2
Unstable 2 2
Structural Problem 1 1
Split 1 1
Difficult or Delayed Activation 1 1
Material Perforation 1 1
Device Displays Incorrect Message 1 1
Nonstandard Device 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 953 1791
No Clinical Signs, Symptoms or Conditions 685 1316
No Known Impact Or Consequence To Patient 639 1090
No Consequences Or Impact To Patient 599 919
No Information 43 129
Insufficient Information 15 58
Perforation 15 15
Burn(s) 14 14
Injury 13 13
Chemical Exposure 13 13
Device Embedded In Tissue or Plaque 13 13
Hearing Impairment 11 11
Tissue Damage 8 8
Foreign Body In Patient 8 8
Cerebrospinal Fluid Leakage 7 7
Hemorrhage/Bleeding 6 6
Radiation Exposure, Unintended 6 6
Unspecified Tissue Injury 6 6
Unintended Radiation Exposure 6 6
Unspecified Infection 5 5
Burn, Thermal 5 7
Nerve Damage 5 5
Spinal Column Injury 4 4
Tinnitus 3 3
Laceration(s) 3 3
Death 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Superficial (First Degree) Burn 2 8
Erythema 2 2
Acoustic Trauma 2 3
Hematoma 2 2
Pain 2 2
Spinal Cord Injury 2 2
Reaction 1 1
Numbness 1 1
Sprain 1 1
Muscle Weakness 1 1
Internal Organ Perforation 1 1
Oversedation 1 1
Inflammation 1 1
Intracranial Hemorrhage 1 1
Hemorrhage, Subdural 1 1
Failure of Implant 1 1
Facial Nerve Paralysis 1 1
Fatigue 1 1
Headache 1 1
Contusion 1 1
Hearing Loss 1 1
Partial thickness (Second Degree) Burn 1 3
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Feb-15-2018
2 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II May-04-2016
3 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Nov-20-2015
4 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Dec-17-2009
5 Stryker Instruments Div. of Stryker Corporation II Jun-09-2016
6 The Anspach Effort, Inc. II Jun-25-2014
7 The Anspach Effort, Inc. II Jan-09-2014
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