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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, finger, constrained, metal/polymer
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Product CodeKWG
Regulation Number 888.3220
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
1 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2017 1 1
2019 6 6
2022 3 3
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Appears to Trigger Rejection 6 6
Unstable 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Fracture 3 3
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 6 6
No Clinical Signs, Symptoms or Conditions 3 3
Pain 3 3
No Consequences Or Impact To Patient 2 2
Injury 1 1
Joint Dislocation 1 1

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