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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
Regulation Description Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
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

MDR Year MDR Reports MDR Events
2022 2 2
2023 41 42
2024 22 25
2025 17 17
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 48 52
Break 40 40
Material Deformation 15 16
No Apparent Adverse Event 14 14
Naturally Worn 5 5
Material Integrity Problem 3 3
Scratched Material 3 3
Contamination /Decontamination Problem 2 2
Material Discolored 1 1
Illegible Information 1 1
Fracture 1 1
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 77
Insufficient Information 16 17

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