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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neurosurgical paddie
Regulation Description Neurosurgical paddie.
Product CodeHBA
Regulation Number 882.4700
Device Class 2


Premarket Reviews
ManufacturerDecision
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 40 40
2017 35 35
2018 58 58
2019 57 57
2020 31 31
2021 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 56 56
Device Misassembled During Manufacturing /Shipping 33 33
Incorrect Device Or Component Shipped 24 24
Material Integrity Problem 17 17
Detachment of Device or Device Component 16 16
Device Contamination with Chemical or Other Material 13 13
Contamination 12 12
Material Frayed 10 10
Contamination /Decontamination Problem 10 10
Device Contaminated During Manufacture or Shipping 9 9
Manufacturing, Packaging or Shipping Problem 7 7
Detachment Of Device Component 7 7
Material Discolored 5 5
Appropriate Term/Code Not Available 5 5
Break 5 5
Failure to Sense 4 4
Use of Device Problem 4 4
Material Separation 3 3
Insufficient Information 3 3
Delivered as Unsterile Product 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Improper or Incorrect Procedure or Method 2 2
Flaked 2 2
Device Operates Differently Than Expected 2 2
Device Or Device Fragments Location Unknown 2 2
Incomplete or Missing Packaging 2 2
Defective Device 1 1
Material Fragmentation 1 1
Unsealed Device Packaging 1 1
Device Packaging Compromised 1 1
Packaging Problem 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Peeled/Delaminated 1 1
Defective Component 1 1
Material Deformation 1 1
Device Disinfection Or Sterilization Issue 1 1
Scratched Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 75 75
No Known Impact Or Consequence To Patient 62 62
No Consequences Or Impact To Patient 52 52
No Clinical Signs, Symptoms or Conditions 24 24
No Patient Involvement 19 19
Device Embedded In Tissue or Plaque 9 9
Foreign Body Reaction 2 2
Failure of Implant 2 2
Therapeutic Effects, Unexpected 1 1
Unintended Radiation Exposure 1 1
Insufficient Information 1 1
Foreign Body In Patient 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
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