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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device hammer, surgical
Product CodeFZY
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 75 75
2020 79 79
2021 69 69
2022 68 68
2023 79 79
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Break 213 213
Device-Device Incompatibility 89 89
Material Twisted/Bent 66 66
Naturally Worn 55 55
Contamination /Decontamination Problem 28 28
Material Deformation 20 20
Material Integrity Problem 8 8
Physical Resistance/Sticking 4 4
Mechanical Jam 4 4
Crack 3 3
Scratched Material 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Illegible Information 3 3
Device Slipped 2 2
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Appropriate Term/Code Not Available 2 2
Entrapment of Device 1 1
Mechanical Problem 1 1
Separation Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Component Missing 1 1
Unexpected Therapeutic Results 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 266 266
No Consequences Or Impact To Patient 109 109
No Patient Involvement 20 20
No Code Available 18 18
Insufficient Information 17 17
Not Applicable 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Known Impact Or Consequence To Patient 2 2
Skin Infection 1 1

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