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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
2019 24 24
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 66 66
Material Fragmentation 13 13
Fracture 12 12
Detachment of Device or Device Component 8 8
Material Integrity Problem 8 8
Material Separation 7 7
Contamination /Decontamination Problem 5 5
Device Fell 4 4
Material Erosion 4 4
Peeled/Delaminated 4 4
Appropriate Term/Code Not Available 3 3
Material Twisted/Bent 3 3
Loose or Intermittent Connection 3 3
Compatibility Problem 3 3
Component Missing 2 2
Material Deformation 2 2
Mechanical Problem 2 2
Difficult to Remove 1 1
Entrapment of Device 1 1
Solder Joint Fracture 1 1
Difficult to Open or Close 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Structural 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
No Known Impact Or Consequence To Patient 16 16
Foreign Body In Patient 15 15
No Consequences Or Impact To Patient 14 14
Device Embedded In Tissue or Plaque 3 3
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 2 2
Ambulation Difficulties 1 1
Spinal Cord Injury 1 1
No Patient Involvement 1 1
No Code Available 1 1
Deformity/ Disfigurement 1 1
No Information 1 1
Nerve Damage 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1
Pain 1 1

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