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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wire, surgical
Product CodeLRN
Regulation Number 888.3030
Device Class 2

MDR Year MDR Reports MDR Events
2014 57 57
2015 24 24
2016 38 38
2017 33 33
2018 58 58
2019 84 84
2020 68 68
2021 118 118
2022 106 106
2023 140 140
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Break 272 272
Material Deformation 172 172
Adverse Event Without Identified Device or Use Problem 125 125
Device-Device Incompatibility 107 107
Entrapment of Device 79 79
Material Fragmentation 48 48
No Apparent Adverse Event 17 17
Device Operates Differently Than Expected 13 13
Material Twisted/Bent 8 8
Mechanical Jam 7 7
Appropriate Term/Code Not Available 6 6
Migration 6 6
Difficult to Remove 6 6
Bent 6 6
Device Slipped 5 5
Migration or Expulsion of Device 4 4
Device Handling Problem 4 4
Material Integrity Problem 4 4
Contamination /Decontamination Problem 4 4
Scratched Material 4 4
Sticking 3 3
Defective Device 3 3
Improper or Incorrect Procedure or Method 2 2
Overheating of Device 2 2
Tear, Rip or Hole in Device Packaging 2 2
Packaging Problem 2 2
Insufficient Information 2 2
Difficult to Advance 2 2
Failure to Cut 1 1
Device Difficult to Maintain 1 1
Failure to Align 1 1
Use of Device Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Expiration Issue 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 1 1
Peeled/Delaminated 1 1
Fracture 1 1
Metal Shedding Debris 1 1
Crack 1 1
Device Dislodged or Dislocated 1 1
Mechanical Problem 1 1
Activation, Positioning or Separation Problem 1 1
Loose or Intermittent Connection 1 1
Fitting Problem 1 1
Deformation Due to Compressive Stress 1 1
Disconnection 1 1
Detachment Of Device Component 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 267 267
Foreign Body In Patient 91 91
No Code Available 87 87
No Consequences Or Impact To Patient 76 76
No Known Impact Or Consequence To Patient 68 68
Device Embedded In Tissue or Plaque 38 38
Pain 38 38
No Patient Involvement 35 35
Non-union Bone Fracture 30 30
Unspecified Infection 29 29
Insufficient Information 25 25
Post Operative Wound Infection 19 19
Failure of Implant 15 15
Unspecified Tissue Injury 14 14
Injury 14 14
Bone Fracture(s) 10 10
Nerve Damage 8 8
Sedation 8 8
Impaired Healing 6 6
Hypersensitivity/Allergic reaction 6 6
Necrosis 5 5
Inflammation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body Reaction 4 4
Discomfort 4 4
No Information 3 3
Skin Inflammation/ Irritation 3 3
Wound Dehiscence 3 3
Swelling/ Edema 3 3
Rupture 2 2
Ambulation Difficulties 2 2
Not Applicable 2 2
Arthritis 2 2
Burn(s) 2 2
Limited Mobility Of The Implanted Joint 2 2
Needle Stick/Puncture 2 2
Swelling 2 2
Bacterial Infection 2 2
Malunion of Bone 2 2
Ulcer 2 2
Tissue Damage 2 2
Pressure Sores 1 1
Infiltration into Tissue 1 1
Hemorrhage/Bleeding 1 1
Physical Asymmetry 1 1
Cerebrospinal Fluid Leakage 1 1
Joint Laxity 1 1
Vessel Or Plaque, Device Embedded In 1 1
Patient Problem/Medical Problem 1 1
Eye Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Oct-21-2019
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