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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
2016 231 231
2017 284 319
2018 253 371
2019 331 331
2020 276 276

Device Problems MDRs with this Device Problem Events in those MDRs
Break 613 766
Fracture 256 256
Tip 105 105
Device Operates Differently Than Expected 74 74
Knife 53 53
Material Fragmentation 49 49
Detachment Of Device Component 42 42
Tear, Rip or Hole in Device Packaging 38 38
Device Inoperable 31 31
Packaging Problem 26 177
Device Contamination with Chemical or Other Material 24 24
Overheating of Device 22 22
Bent 21 21
Metal Shedding Debris 20 20
Detachment of Device or Device Component 18 18
Mechanical Problem 18 18
Delivered as Unsterile Product 18 18
Vibration 17 17
Contamination /Decontamination Problem 14 14
Device Contaminated During Manufacture or Shipping 13 13
Material Deformation 13 13
Shaft 11 11
Adverse Event Without Identified Device or Use Problem 9 9
Difficult to Remove 9 9
Material Separation 9 9
Cable, Electrical 9 9
Bearings 8 8
Cutter/Blade 8 8
Device Packaging Compromised 8 8
Mechanical Jam 7 7
Torn Material 7 7
Crack 7 7
Dull, Blunt 7 7
Protector 7 7
Motor(s) 6 6
Loose or Intermittent Connection 6 6
Fitting Problem 6 6
Output below Specifications 6 6
Defective Component 6 6
Device Operational Issue 6 6
Component Missing 5 5
Naturally Worn 5 5
Insufficient Information 5 5
Component Falling 5 5
Corroded 5 5
Noise, Audible 4 4
Temperature Problem 4 4
No Apparent Adverse Event 4 4
Failure to Cut 4 4
Defective Device 4 4
Device Or Device Fragments Location Unknown 4 4
Material Disintegration 4 4
Gears 4 4
Difficult To Position 4 4
Particulates 3 3
Smoking 3 3
Fluid Leak 3 3
SAW (Surface Acoustic Wave Device) 3 3
Failure to Power Up 3 3
Material Twisted/Bent 3 3
Partial Blockage 3 3
Housing 3 3
Intermittent Continuity 3 3
Material Integrity Problem 3 3
Device Subassembly 3 3
Handpiece 3 3
Improper or Incorrect Procedure or Method 3 3
Connection Problem 3 3
Device Damaged Prior to Use 2 2
Complete Loss of Power 2 2
Excessive Heating 2 2
Sticking 2 2
Entrapment of Device 2 2
Flaked 2 2
Material Frayed 2 2
Power Cord 2 2
Thermal Decomposition of Device 2 2
Appropriate Term/Code Not Available 2 2
Unsealed Device Packaging 2 2
Melted 2 2
Device Emits Odor 2 2
Loss of Power 2 2
Stretched 1 1
Device Abrasion From Instrument Or Another Object 1 1
Migration or Expulsion of Device 1 1
Air Leak 1 1
Charred 1 1
Failure to Deliver Energy 1 1
Device Expiration Issue 1 1
Disassembly 1 1
Screw 1 1
Ring 1 1
Flange 1 1
Foot Switch 1 1
Tube 1 1
Patient Device Interaction Problem 1 1
Material Too Soft/Flexible 1 1
Material Split, Cut or Torn 1 1
Misassembled During Installation 1 1
Unclear Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 481 634
No Known Impact Or Consequence To Patient 433 506
No Patient Involvement 233 350
No Clinical Signs, Symptoms or Conditions 119 119
Device Embedded In Tissue or Plaque 40 40
Foreign Body In Patient 34 34
No Information 23 23
Radiation Exposure, Unintended 16 16
No Code Available 14 14
Insufficient Information 12 12
Not Applicable 9 9
Burn(s) 8 8
Burn, Thermal 7 7
Patient Problem/Medical Problem 4 4
Injury 4 4
Laceration(s) 4 4
Pain 3 3
Tissue Damage 3 3
Abrasion 3 3
Non-union Bone Fracture 2 2
Necrosis 2 2
Paralysis 1 1
Purulent Discharge 1 1
Edema 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Complaint, Ill-Defined 1 1
Limited Mobility Of The Implanted Joint 1 1
Unspecified Tissue Injury 1 1
Extravasation 1 1
Skin Discoloration 1 1
Swelling 1 1
Perforation of Vessels 1 1
Hip Fracture 1 1
Superficial (First Degree) Burn 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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