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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
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
2019 19 19
2020 7 7
2021 10 10
2022 10 10
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Material Integrity Problem 5 5
Detachment of Device or Device Component 5 5
Material Puncture/Hole 4 4
Fracture 3 3
Material Fragmentation 3 3
Unsealed Device Packaging 3 3
No Apparent Adverse Event 2 2
Explosion 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Unintended Movement 1 1
Mechanical Problem 1 1
Use of Device Problem 1 1
Incomplete or Missing Packaging 1 1
Separation Failure 1 1
Device Damaged by Another Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Consequences Or Impact To Patient 18 18
Foreign Body In Patient 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 5 5
Device Embedded In Tissue or Plaque 3 3
Hydrocephalus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Injury 1 1
No Patient Involvement 1 1

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