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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
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEISTER MEDIZIN TECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MORPHEUS AG
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 12 12
2022 13 13
2023 10 10
2024 9 9
2025 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Detachment of Device or Device Component 11 11
Material Fragmentation 4 4
Fracture 3 3
Device Fell 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Separation 2 2
Off-Label Use 1 1
Output Problem 1 1
Activation Problem 1 1
Component Missing 1 1
Dent in Material 1 1
Material Twisted/Bent 1 1
Failure to Cut 1 1
No Apparent Adverse Event 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
Insufficient Information 14 14
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Folsom Metal Products, Inc. II Dec-06-2024
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