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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
2020 1 1
2021 4 4
2022 2 2
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Application Program Problem 3 3
Computer Software Problem 2 2
Mechanical Problem 2 2
Failure to Read Input Signal 1 1
Device Difficult to Program or Calibrate 1 1
Use of Incorrect Control/Treatment Settings 1 1
Device Slipped 1 1
Device-Device Incompatibility 1 1
Communication or Transmission Problem 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
Unintended Radiation Exposure 1 1
Pain 1 1
No Known Impact Or Consequence To Patient 1 1

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