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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurosurgical paddie
Regulation Description Neurosurgical paddie.
Product CodeHBA
Regulation Number 882.4700
Device Class 2

MDR Year MDR Reports MDR Events
2021 44 44
2022 28 29
2023 29 29
2024 27 27
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 33 33
Material Integrity Problem 15 15
Material Separation 15 15
Component Missing 11 11
Detachment of Device or Device Component 6 6
Insufficient Information 5 5
Contamination /Decontamination Problem 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Material Frayed 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Separation Problem 3 3
Flaked 3 3
Extra Components 3 3
Material Discolored 2 2
Use of Device Problem 2 2
Appropriate Term/Code Not Available 2 2
Compatibility Problem 1 2
Device Contaminated During Manufacture or Shipping 1 1
Material Split, Cut or Torn 1 1
Break 1 1
Peeled/Delaminated 1 1
Device Damaged Prior to Use 1 1
Material Disintegration 1 1
Fail-Safe Did Not Operate 1 1
Defective Device 1 1
Material Fragmentation 1 1
Delivered as Unsterile Product 1 1
Component Misassembled 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 110
Insufficient Information 9 9
Nausea 8 8
Headache 8 8
Dizziness 3 3
Vomiting 3 3
Pain 2 2
Bradycardia 2 2
Presyncope 1 1
Inflammation 1 1
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Nasal Obstruction 1 1
Airway Obstruction 1 1
Device Embedded In Tissue or Plaque 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company, LLC II Nov-01-2024
2 Integra LifeSciences Corp. II Oct-29-2024
3 Integra LifeSciences Corp. II Jan-06-2023
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