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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
2018 2 2
2019 3 3
2021 1 1
2022 3 3
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Difficult to Remove 2 2
Shipping Damage or Problem 1 1
Component Missing 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Appropriate Term/Code Not Available 1 1
Failure to Eject 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Code Available 3 3
Hypersensitivity/Allergic reaction 2 2
Skin Irritation 2 2
No Known Impact Or Consequence To Patient 1 1
Unspecified Infection 1 1
Unspecified Tissue Injury 1 1
Insufficient Information 1 1
Cerebrospinal Fluid Leakage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Sep-13-2019
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