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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device internal hinged elbow fixator
Definition The hinged internal fixator is intended to treat joint dislocations, more specifically of the elbow joint. The device is intended to be removed once stability is achieved.
Product CodeOZI
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 7 7
2021 1 1
2022 5 5
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 9 9
Fracture 7 7
Mechanical Problem 4 4
Off-Label Use 3 3
Installation-Related Problem 2 2
Break 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Device Dislodged or Dislocated 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 15 15
Joint Laxity 6 6
Joint Dislocation 2 2
Subluxation 2 2
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Laceration(s) 1 1
Pain 1 1

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