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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instruments designed for press-fit osteochondral implants
Definition The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.
Product CodeQBO
Regulation Number 888.4505
Device Class 2


Premarket Reviews
ManufacturerDecision
CARTIVA, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 2 2
2023 41 41
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Device-Device Incompatibility 18 18
No Apparent Adverse Event 14 14
Material Deformation 5 5
Naturally Worn 2 2
Scratched Material 2 2
Contamination /Decontamination Problem 2 2
Corroded 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Insufficient Information 2 2

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