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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cutter, wire
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXZ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 36 36
2020 24 24
2021 44 44
2022 37 37
2023 33 33
2024 34 34
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 116 116
Material Integrity Problem 32 32
Failure to Cut 13 13
Fracture 13 13
Dull, Blunt 10 10
Material Deformation 7 7
Mechanical Problem 5 5
Crack 4 4
Material Fragmentation 3 3
Contamination /Decontamination Problem 3 3
Naturally Worn 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Device Slipped 2 2
Activation, Positioning or Separation Problem 2 2
Device-Device Incompatibility 1 1
Material Frayed 1 1
Mechanical Jam 1 1
Defective Device 1 1
Device Fell 1 1
Flaked 1 1
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Packaging Problem 1 1
Corroded 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 136 136
No Consequences Or Impact To Patient 28 28
No Patient Involvement 15 15
Insufficient Information 10 10
No Known Impact Or Consequence To Patient 9 9
Foreign Body In Patient 6 6
No Information 3 3
No Code Available 3 3
Tissue Damage 1 1
Device Embedded In Tissue or Plaque 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Dec-22-2020
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