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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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
2019 57 57
2020 31 31
2021 44 44
2022 28 28
2023 29 29
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination 33 33
Device Misassembled During Manufacturing /Shipping 29 29
Material Integrity Problem 21 21
Component Missing 18 18
Contamination /Decontamination Problem 14 14
Material Separation 14 14
Material Frayed 10 10
Manufacturing, Packaging or Shipping Problem 9 9
Detachment of Device or Device Component 7 7
Flaked 4 4
Device Contaminated During Manufacture or Shipping 4 4
Separation Problem 4 4
Extra Components 3 3
Delivered as Unsterile Product 3 3
Inadequacy of Device Shape and/or Size 3 3
Use of Device Problem 2 2
Incomplete or Missing Packaging 2 2
Defective Device 2 2
Material Discolored 2 2
Break 2 2
Appropriate Term/Code Not Available 2 2
Failure to Sense 2 2
Compatibility Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Scratched Material 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Loss of or Failure to Bond 1 1
Material Disintegration 1 1
Peeled/Delaminated 1 1
Material Fragmentation 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 99
No Consequences Or Impact To Patient 46 46
No Known Impact Or Consequence To Patient 34 34
Insufficient Information 7 7
No Information 3 3
No Patient Involvement 2 2
Failure of Implant 2 2
Therapeutic Effects, Unexpected 1 1
Foreign Body In Patient 1 1
Unintended Radiation Exposure 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jan-06-2023
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