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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
2016 28 28
2017 26 26
2018 24 24
2019 24 24
2020 29 29
2021 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 88 88
Fracture 18 18
Material Fragmentation 14 14
Detachment Of Device Component 6 6
Material Deformation 5 5
Detachment of Device or Device Component 5 5
Component Missing 4 4
Material Integrity Problem 4 4
Device Fell 4 4
Material Erosion 4 4
Peeled/Delaminated 4 4
Bent 3 3
Appropriate Term/Code Not Available 3 3
Material Separation 2 2
Device Dislodged or Dislocated 2 2
Material Twisted/Bent 2 2
Loose or Intermittent Connection 2 2
Component Falling 2 2
Corroded 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Delivered as Unsterile Product 1 1
Solder Joint Fracture 1 1
Contamination /Decontamination Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Mechanical Problem 1 1
Difficult to Remove 1 1
Structural Problem 1 1
Failure to Cut 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 61 61
No Clinical Signs, Symptoms or Conditions 25 25
No Consequences Or Impact To Patient 17 17
Foreign Body In Patient 16 16
No Patient Involvement 12 12
Device Embedded In Tissue or Plaque 9 9
Insufficient Information 9 9
No Information 4 4
No Code Available 4 4
Hemorrhage/Bleeding 2 2
Pain 2 2
Patient Problem/Medical Problem 2 2
Injury 1 1
Nerve Damage 1 1
Missing Value Reason 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Ambulation Difficulties 1 1

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