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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, arthroscopic
Product CodeNBH
Regulation Number 888.1100
Device Class 1

MDR Year MDR Reports MDR Events
2019 358 358
2020 340 340
2021 389 389
2022 334 334
2023 491 491
2024 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Break 875 875
Material Separation 152 152
Material Deformation 140 140
Material Twisted/Bent 121 121
Degraded 109 109
Detachment of Device or Device Component 102 102
Difficult to Open or Close 100 100
Mechanical Jam 84 84
Device Contaminated During Manufacture or Shipping 53 53
Device-Device Incompatibility 40 40
Dull, Blunt 38 38
Material Fragmentation 33 33
Adverse Event Without Identified Device or Use Problem 28 28
Fracture 25 25
Flaked 22 22
Device Contamination with Chemical or Other Material 21 21
Corroded 16 16
Failure to Cut 16 16
Appropriate Term/Code Not Available 15 15
Component Missing 15 15
Mechanical Problem 15 15
Crack 14 14
Insufficient Information 13 13
Defective Device 11 11
Physical Resistance/Sticking 11 11
Leak/Splash 10 10
Fluid/Blood Leak 10 10
Device Markings/Labelling Problem 10 10
Use of Device Problem 10 10
Material Split, Cut or Torn 9 9
Device Dislodged or Dislocated 8 8
Material Integrity Problem 8 8
Difficult to Remove 7 7
Delivered as Unsterile Product 7 7
Sharp Edges 7 7
Entrapment of Device 7 7
Packaging Problem 6 6
Contamination /Decontamination Problem 6 6
Illegible Information 5 5
Material Discolored 5 5
Failure to Advance 5 5
Firing Problem 5 5
Scratched Material 4 4
Loose or Intermittent Connection 4 4
Failure to Align 4 4
Problem with Sterilization 4 4
Failure to Cycle 4 4
Connection Problem 4 4
Solder Joint Fracture 3 3
Unstable 3 3
Contamination 3 3
Device Fell 3 3
Device Damaged Prior to Use 3 3
Difficult to Advance 3 3
Device Damaged by Another Device 3 3
Contamination of Device Ingredient or Reagent 2 2
Unintended Movement 2 2
Inadequacy of Device Shape and/or Size 2 2
Positioning Problem 2 2
Nonstandard Device 2 2
Overheating of Device 2 2
Separation Problem 2 2
Noise, Audible 2 2
Device Slipped 2 2
Output Problem 2 2
Product Quality Problem 2 2
Misfire 2 2
Component Misassembled 2 2
Activation Problem 2 2
Retraction Problem 1 1
Capturing Problem 1 1
Difficult or Delayed Separation 1 1
Activation, Positioning or Separation Problem 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Display/Image 1 1
Deformation Due to Compressive Stress 1 1
Obstruction of Flow 1 1
Material Frayed 1 1
Residue After Decontamination 1 1
Misassembled 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Migration or Expulsion of Device 1 1
Infusion or Flow Problem 1 1
Material Disintegration 1 1
Device Reprocessing Problem 1 1
Ejection Problem 1 1
Display or Visual Feedback Problem 1 1
Malposition of Device 1 1
Material Rupture 1 1
Disconnection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Insert 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Positioning Failure 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1253 1253
No Known Impact Or Consequence To Patient 226 226
No Consequences Or Impact To Patient 218 218
Foreign Body In Patient 119 119
Insufficient Information 91 91
No Information 47 47
Not Applicable 32 32
No Patient Involvement 32 32
Device Embedded In Tissue or Plaque 30 30
No Code Available 17 17
Pain 13 13
Injury 13 13
Tissue Damage 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Failure of Implant 5 5
Laceration(s) 5 5
Unspecified Tissue Injury 4 4
Swelling/ Edema 3 3
Rupture 3 3
Extravasation 3 3
Perforation 3 3
Hypersensitivity/Allergic reaction 2 2
Exposure to Body Fluids 1 1
Capsular Contracture 1 1
Nerve Damage 1 1
Neuropathy 1 1
Itching Sensation 1 1
Burning Sensation 1 1
Numbness 1 1
Post Operative Wound Infection 1 1
Needle Stick/Puncture 1 1
Inadequate Osseointegration 1 1
Patient Problem/Medical Problem 1 1
Paresthesia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Aug-12-2019
2 Smith & Nephew, Inc. II Oct-27-2020
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