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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
AMERICAN SURGICAL COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 43 43
2015 38 38
2016 40 40
2017 35 35
2018 58 58
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
Component Missing 77 77
Contamination 37 37
Device Misassembled During Manufacturing /Shipping 33 33
Incorrect Device Or Component Shipped 30 30
Appropriate Term/Code Not Available 27 27
Device Contamination with Chemical or Other Material 24 24
Material Integrity Problem 21 21
Detachment of Device or Device Component 19 19
Material Separation 18 18
Material Frayed 17 17
Contamination /Decontamination Problem 15 15
Manufacturing, Packaging or Shipping Problem 11 11
Device Contaminated During Manufacture or Shipping 10 10
Detachment Of Device Component 10 10
Material Discolored 8 8
Delivered as Unsterile Product 6 6
Break 5 5
Flaked 4 4
Failure to Sense 4 4
Use of Device Problem 4 4
Incomplete or Missing Packaging 4 4
Packaging Problem 4 4
Separation Problem 4 4
Extra Components 3 3
Insufficient Information 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Operates Differently Than Expected 3 3
Improper or Incorrect Procedure or Method 3 3
Product Quality Problem 3 3
Peeled/Delaminated 2 2
Material Fragmentation 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 2 2
Device Issue 2 2
Torn Material 2 2
Material Split, Cut or Torn 2 2
Unintended Movement 1 1
Component Misassembled 1 1
Scratched Material 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Split 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Device Disinfection Or Sterilization Issue 1 1
Compatibility Problem 1 1
Unsealed Device Packaging 1 1
Loss of or Failure to Bond 1 1
Material Disintegration 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 111 111
No Clinical Signs, Symptoms or Conditions 99 99
No Known Impact Or Consequence To Patient 74 74
No Consequences Or Impact To Patient 56 56
No Patient Involvement 31 31
No Code Available 15 15
Device Embedded In Tissue or Plaque 9 9
Insufficient Information 7 7
Foreign Body In Patient 2 2
Foreign Body Reaction 2 2
Failure of Implant 2 2
Therapeutic Effects, Unexpected 1 1
Tissue Damage 1 1
Injury 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Codman & Shurtleff, Inc. II Oct-20-2010
3 Integra LifeSciences Corp. II Jan-06-2023
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