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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device punch, surgical
Product CodeLRY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2017 71 71
2018 83 83
2019 77 77
2020 86 86
2021 68 68
2022 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Break 168 168
Device-Device Incompatibility 76 76
Material Twisted/Bent 59 59
Material Deformation 54 54
Naturally Worn 35 35
Appropriate Term/Code Not Available 20 20
Loose or Intermittent Connection 13 13
Failure to Cut 12 12
Material Fragmentation 11 11
Material Integrity Problem 10 10
Connection Problem 9 9
Crack 8 8
Mechanical Jam 8 8
Difficult to Remove 7 7
Physical Resistance/Sticking 5 5
Mechanical Problem 5 5
Dull, Blunt 5 5
Entrapment of Device 5 5
Sharp Edges 3 3
Defective Device 3 3
Material Too Soft/Flexible 3 3
Insufficient Information 3 3
Detachment of Device or Device Component 3 3
Fracture 3 3
Illegible Information 3 3
Bent 2 2
Device Issue 2 2
Device Contaminated During Manufacture or Shipping 2 2
Unintended Movement 2 2
Therapeutic or Diagnostic Output Failure 2 2
Scratched Material 2 2
Contamination /Decontamination Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Positioning Problem 1 1
Component Misassembled 1 1
Packaging Problem 1 1
Difficult or Delayed Separation 1 1
Deformation Due to Compressive Stress 1 1
Disassembly 1 1
Nonstandard Device 1 1
Retraction Problem 1 1
Device Slipped 1 1
Component Missing 1 1
Device Contamination with Chemical or Other Material 1 1
Failure To Adhere Or Bond 1 1
Detachment Of Device Component 1 1
Product Quality Problem 1 1
Fitting Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 173 173
No Clinical Signs, Symptoms or Conditions 124 124
No Known Impact Or Consequence To Patient 59 59
Not Applicable 30 30
No Information 25 25
No Code Available 25 25
Insufficient Information 12 12
Laceration(s) 3 3
Device Embedded In Tissue or Plaque 2 2
Hemorrhage/Bleeding 2 2
Foreign Body In Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Swelling 1 1
Skin Tears 1 1
Great Vessel Perforation 1 1
Joint Disorder 1 1
Pain 1 1
Needle Stick/Puncture 1 1
Intraoperative Pain 1 1
Excessive Tear Production 1 1
Wound Dehiscence 1 1
Failure of Implant 1 1
Infiltration into Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alto Development Corp II Mar-01-2018
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