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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, non-powered
Regulation Description Nonpowered neurosurgical instrument.
Product CodeHAO
Regulation Number 882.4535
Device Class 1


Premarket Reviews
ManufacturerDecision
SHENZHEN SHINEYARD MEDICAL DEVICE CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 7 7
2021 10 10
2022 10 10
2023 12 12
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 12 12
Material Fragmentation 4 4
Material Puncture/Hole 4 4
Unsealed Device Packaging 3 3
Detachment of Device or Device Component 3 3
Material Integrity Problem 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Physical Resistance/Sticking 1 1
Material Perforation 1 1
Device Damaged by Another Device 1 1
Explosion 1 1
Unintended Movement 1 1
Mechanical Problem 1 1
Incomplete or Missing Packaging 1 1
Packaging Problem 1 1
Separation Failure 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 6 6
Insufficient Information 5 5
Foreign Body In Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1

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