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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 29 29
2021 26 26
2022 23 23
2023 14 14
2024 24 24
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 50 50
Material Fragmentation 11 11
Fracture 9 9
Material Integrity Problem 8 8
Material Separation 7 7
Detachment of Device or Device Component 6 6
Contamination /Decontamination Problem 5 5
Peeled/Delaminated 4 4
Material Erosion 4 4
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Compatibility Problem 3 3
Device Fell 3 3
Loose or Intermittent Connection 2 2
Material Deformation 2 2
Component Missing 2 2
Mechanical Problem 2 2
Solder Joint Fracture 1 1
Entrapment of Device 1 1
Difficult to Open or Close 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80 80
Insufficient Information 16 16
Foreign Body In Patient 11 11
No Known Impact Or Consequence To Patient 7 7
No Consequences Or Impact To Patient 5 5
Device Embedded In Tissue or Plaque 3 3
Hemorrhage/Bleeding 2 2
Patient Problem/Medical Problem 2 2
Deformity/ Disfigurement 1 1
No Patient Involvement 1 1
Nerve Damage 1 1
Unspecified Tissue Injury 1 1
Spinal Cord Injury 1 1
Pain 1 1
No Code Available 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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