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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur
Product CodeHTX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 26 26
2018 24 24
2019 24 24
2020 29 29
2021 26 26
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Break 78 78
Fracture 17 17
Material Fragmentation 11 11
Detachment of Device or Device Component 7 7
Material Integrity Problem 6 6
Material Separation 6 6
Material Deformation 5 5
Device Fell 4 4
Peeled/Delaminated 4 4
Component Missing 4 4
Material Erosion 4 4
Bent 3 3
Detachment Of Device Component 3 3
Loose or Intermittent Connection 3 3
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 1 1
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Delivered as Unsterile Product 1 1
Entrapment of Device 1 1
Solder Joint Fracture 1 1
Structural Problem 1 1
Failure to Cut 1 1
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 44 44
No Clinical Signs, Symptoms or Conditions 41 41
No Consequences Or Impact To Patient 17 17
Foreign Body In Patient 16 16
Insufficient Information 14 14
No Patient Involvement 8 8
Device Embedded In Tissue or Plaque 6 6
No Information 3 3
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Pain 2 2
Hemorrhage/Bleeding 2 2
Failure of Implant 1 1
Nerve Damage 1 1
Injury 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Ambulation Difficulties 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jul-03-2017
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