Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2021 10 10
2022 10 10
2023 12 12
2024 6 6
2025 8 8
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 16 16
Material Puncture/Hole 4 4
Material Fragmentation 4 4
Detachment of Device or Device Component 4 4
Unsealed Device Packaging 3 3
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Mechanical Problem 1 1
Incomplete or Missing Packaging 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Failure to Auto Stop 1 1
Separation Failure 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Device Damaged by Another Device 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Foreign Body In Patient 5 5
Insufficient Information 5 5
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

-
-