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TPLC
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Device
instrument, surgical, non-powered
Regulation Description
Nonpowered neurosurgical instrument.
Product Code
HAO
Regulation Number
882.4535
Device Class
1
Premarket Reviews
Manufacturer
Decision
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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