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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, scalp
Product CodeHBO
Regulation Number 882.4150
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4
2019 12 12
2020 2 2
2021 5 5
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Compatibility Problem 11 11
Break 4 4
Material Fragmentation 2 2
Contamination /Decontamination Problem 2 2
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Problem 1 1
Peeled/Delaminated 1 1
Contamination 1 1
Material Discolored 1 1
Incorrect Device Or Component Shipped 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Failure to Eject 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 15 15
No Clinical Signs, Symptoms or Conditions 8 8
Foreign Body In Patient 3 3
No Information 2 2
Unspecified Infection 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Aug-06-2021
2 Medtronic Neurosurgery II Sep-21-2018
3 Medtronic Neurosurgery II Feb-15-2018
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