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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pin, fixation, threaded, metallic
Product CodeNDM
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 89 89
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 89 89
Device Dislodged or Dislocated 3 3
Break 2 2
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 77 77
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Subluxation 3 3
Deformity/ Disfigurement 3 3
Non-union Bone Fracture 2 2
Foreign Body In Patient 1 1
Necrosis 1 1
Arthritis 1 1
Failure of Implant 1 1

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