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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device replacement, ossicular prosthesis, total
Regulation Description Total ossicular replacement prosthesis.
Product CodeETA
Regulation Number 874.3495
Device Class 2

MDR Year MDR Reports MDR Events
2016 12 12
2017 9 9
2019 9 9
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Extrusion 5 5
Material Fragmentation 5 5
Material Separation 4 4
Unexpected Therapeutic Results 3 3
Loose or Intermittent Connection 2 2
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 11 11
Failure of Implant 9 9
No Known Impact Or Consequence To Patient 4 4
Hearing Loss 4 4
Erosion 2 2
Therapeutic Response, Decreased 2 2
Impaired Healing 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
Dizziness 1 1
Hearing Impairment 1 1
Perforation 1 1
Therapeutic Effects, Unexpected 1 1
Vertigo 1 1

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