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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drills, burrs, trephines & accessories (manual)
Product CodeHBG
Regulation Number 882.4300
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2021 1 1
2022 3 3
2023 3 3
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Device-Device Incompatibility 4 4
Component or Accessory Incompatibility 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Failure to Eject 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Shipping Damage or Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
No Code Available 3 3
Hypersensitivity/Allergic reaction 2 2
Skin Irritation 2 2
Insufficient Information 2 2
Unspecified Infection 1 1
Failure of Implant 1 1
Hematoma 1 1
Intracranial Hemorrhage 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Sep-13-2019
2 Integra LifeSciences Corp. II May-20-2024
3 Integra LifeSciences Corp. II Feb-28-2024
4 Integra LifeSciences Corp. II Dec-06-2023
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