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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurosurgical ultrasonic instruments
Product CodeLBK
Device Class Unclassified

MDR Year MDR Reports MDR Events
2014 9 9
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 2 2
Overheating of Device 2 2
Device Packaging Compromised 2 2
Break 2 2
Crack 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Pressure Problem 1 1
Material Too Rigid or Stiff 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Mar-08-2013
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