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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

MDR Year MDR Reports MDR Events
2017 26 26
2018 10 10
2019 19 19
2020 7 7
2021 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 43 43
Material Integrity Problem 5 5
Material Puncture/Hole 4 4
Detachment of Device or Device Component 3 3
Tear, Rip or Hole in Device Packaging 2 2
Fracture 2 2
Contamination /Decontamination Problem 2 2
Material Twisted/Bent 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Explosion 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Material Fragmentation 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Unintended Collision 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Degraded 1 1
Separation Failure 1 1
Difficult to Open or Remove Packaging Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Metal Shedding Debris 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 29 29
No Known Impact Or Consequence To Patient 17 17
No Patient Involvement 6 6
Foreign Body In Patient 5 5
No Clinical Signs, Symptoms or Conditions 5 5
No Information 4 4
Device Embedded In Tissue or Plaque 2 2
Laceration(s) 1 1
No Code Available 1 1
Hydrocephalus 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Injury 1 1
Osteolysis 1 1

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