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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device software for diagnosis/treatment
Definition Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Product CodeOSN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 4 4
2022 2 2
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Problem 4 4
Break 4 4
Mechanical Problem 2 2
Computer Software Problem 2 2
Device Slipped 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device-Device Incompatibility 1 1
Failure to Read Input Signal 1 1
Communication or Transmission Problem 1 1
Device Difficult to Program or Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 2 2
Pain 1 1
No Consequences Or Impact To Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 OrthoPediatrics Corp II Nov-22-2022
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