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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor, self-retaining, for neurosurgery
Product CodeGZT
Regulation Number 882.4800
Device Class 2


Premarket Reviews
ManufacturerDecision
MINNETRONIX NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 1
THOMPSON SURGICAL INSTRUMENTS INC.
  SUBSTANTIALLY EQUIVALENT 1
VYCOR MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 3 3
2021 2 2
2022 4 4
2023 2 2
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6 6
Mechanical Problem 4 4
Crack 2 2
Optical Problem 2 2
Material Separation 2 2
Mechanical Jam 2 2
Device Slipped 1 1
Device-Device Incompatibility 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 1 1
Injury 1 1

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