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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chair, neurosurgical
Product CodeHBN
Regulation Number 882.4125
Device Class 1

MDR Year MDR Reports MDR Events
2018 11 11
2019 4 4
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Product Quality Problem 5 5
Component Missing 4 4
Device Operational Issue 2 2
Device Fell 1 1
Failure to Sense 1 1
Use of Device Problem 1 1
Incomplete or Missing Packaging 1 1
Defective Device 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 3 3
No Patient Involvement 3 3
No Information 2 2
Therapeutic Effects, Unexpected 1 1

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