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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rongeur, manual
Product CodeHAE
Regulation Number 882.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
ACE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
MORPHEUS AG
  SUBSTANTIALLY EQUIVALENT 3
WIGGINS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 24 24
2020 25 25
2021 12 12
2022 13 13
2023 10 10
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 54 54
Detachment of Device or Device Component 15 15
Fracture 9 9
Device Fell 7 7
Material Fragmentation 3 3
Physical Resistance/Sticking 3 3
Material Separation 3 3
Dent in Material 2 2
Failure to Cut 2 2
Noise, Audible 2 2
Scratched Material 2 2
Component Missing 1 1
Material Twisted/Bent 1 1
Device Damaged by Another Device 1 1
Misassembly During Maintenance/Repair 1 1
Device Dislodged or Dislocated 1 1
Difficult to Open or Close 1 1
Dull, Blunt 1 1
Off-Label Use 1 1
Output Problem 1 1
Activation Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
No Known Impact Or Consequence To Patient 21 21
Insufficient Information 13 13
No Consequences Or Impact To Patient 12 12
Foreign Body In Patient 6 6
Device Embedded In Tissue or Plaque 2 2
Failure of Implant 1 1
No Code Available 1 1
No Information 1 1
Missing Value Reason 1 1

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