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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
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
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
2021 4 4
2022 2 2
2023 9 9

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

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