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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 (compound, powered)
Regulation Description Powered compound cranial drills, burrs, trephines, and their accessories.
Product CodeHBF
Regulation Number 882.4305
Device Class 2


Premarket Reviews
ManufacturerDecision
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
MICROMAR IND. COM. LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Auto Stop 301
Dull, Blunt 35
Device Remains Activated 27
Adverse Event Without Identified Device or Use Problem 23
Use of Device Problem 22
Mechanical Problem 8
Insufficient Information 7
Difficult to Remove 5
Device Operational Issue 5
Fracture 4
Appropriate Term/Code Not Available 4
Peeled / Delaminated 4
Device Contamination with Chemical or Other Material 4
Material Fragmentation 4
Plunge 4
Disconnection 3
Metal Shedding Debris 3
Fail-Safe Problem 3
Separation Problem 2
Material Separation 2
Device Issue 2
Loss of Power 1
Unsealed Device Packaging 1
Unintended Movement 1
Break 1
Flaked 1
Particulates 1
Failure to Sense 1
Device Operates Differently Than Expected 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1
Material Discolored 1
Total Device Problems 482


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