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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade, saw, general & plastic surgery, surgical
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFA
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2017 284 319
2018 253 371
2019 331 331
2020 276 276
2021 390 390

Device Problems MDRs with this Device Problem Events in those MDRs
Break 621 774
Fracture 422 422
Material Fragmentation 79 79
Device Operates Differently Than Expected 56 56
Tear, Rip or Hole in Device Packaging 40 40
Mechanical Jam 33 33
Packaging Problem 29 180
Detachment Of Device Component 23 23
Detachment of Device or Device Component 20 20
Complete Loss of Power 20 20
Dull, Blunt 19 19
Overheating of Device 19 19
Device Inoperable 19 19
Contamination /Decontamination Problem 17 17
Delivered as Unsterile Product 17 17
Mechanical Problem 15 15
Device Contaminated During Manufacture or Shipping 15 15
Material Deformation 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Device Contamination with Chemical or Other Material 12 12
Material Separation 12 12
Vibration 12 12
Bent 11 11
Entrapment of Device 9 9
Difficult to Remove 8 8
Separation Problem 8 8
Metal Shedding Debris 7 7
Contamination 6 6
Output below Specifications 6 6
Device Packaging Compromised 5 5
Material Twisted/Bent 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 5 5
Insufficient Cooling 5 5
Smoking 5 5
Defective Component 4 4
Failure to Cut 4 4
Fitting Problem 4 4
Difficult To Position 4 4
Material Disintegration 4 4
Crack 4 4
Flaked 4 4
No Apparent Adverse Event 4 4
Material Integrity Problem 4 4
Noise, Audible 3 3
Fluid Leak 3 3
Loose or Intermittent Connection 3 3
Melted 3 3
Corroded 3 3
Thermal Decomposition of Device 3 3
Failure to Power Up 3 3
Particulates 3 3
Peeled/Delaminated 3 3
Component Missing 3 3
Device Operational Issue 3 3
Self-Activation or Keying 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Intermittent Continuity 2 2
Degraded 2 2
Material Discolored 2 2
Disconnection 2 2
Device Emits Odor 2 2
Material Frayed 2 2
Excessive Heating 2 2
Scratched Material 2 2
Temperature Problem 2 2
Naturally Worn 2 2
Output Problem 2 2
Premature Separation 2 2
Misassembled During Installation 1 1
Unclear Information 1 1
Power Problem 1 1
Device-Device Incompatibility 1 1
Fail-Safe Problem 1 1
Failure to Auto Stop 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Activation Problem 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Difficult to Insert 1 1
Leak/Splash 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Device Abrasion From Instrument Or Another Object 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Air Leak 1 1
Failure To Adhere Or Bond 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 453 453
No Consequences Or Impact To Patient 426 579
No Known Impact Or Consequence To Patient 347 420
No Patient Involvement 185 302
Insufficient Information 92 92
Foreign Body In Patient 47 47
Device Embedded In Tissue or Plaque 27 27
No Information 18 18
No Code Available 11 11
Burn(s) 10 10
Not Applicable 9 9
Radiation Exposure, Unintended 8 8
Burn, Thermal 7 7
Patient Problem/Medical Problem 4 4
Laceration(s) 4 4
Injury 4 4
Tissue Damage 3 3
Pain 3 3
Abrasion 3 3
Superficial (First Degree) Burn 2 2
Necrosis 2 2
Bone Fracture(s) 2 2
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Purulent Discharge 1 1
Edema 1 1
Extravasation 1 1
Paralysis 1 1
Skin Discoloration 1 1
Swelling 1 1
Perforation of Vessels 1 1
Unspecified Tissue Injury 1 1
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Apr-24-2019
2 Synvasive Technology Inc II Apr-06-2020
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