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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur, manual
Regulation Description Manual rongeur.
Product CodeHAE
Regulation Number 882.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
INTEGRA
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 12
Fracture 10
Other (for use when an appropriate device code cannot be identified) 8
No code available 7
Device operates differently than expected 3
Difficult to advance 3
No Information 3
No Known Device Problem 2
Dent in material 2
Dislodged or dislocated 2
Detachment of device component 2
Component falling 1
Component missing 1
Mechanical issue 1
Material separation 1
Inadequate service 1
Maintenance does not comply to manufacturers recommendations 1
Bent 1
Total Device Problems 61

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