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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neurological tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 7 7
2019 3 3
2020 8 8
2021 9 9
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 6 6
Material Fragmentation 4 4
Break 4 4
Component Incompatible 3 3
Material Frayed 3 3
Detachment of Device or Device Component 3 3
Appropriate Term/Code Not Available 3 3
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Contamination 2 2
Crack 1 1
Fire 1 1
Loose or Intermittent Connection 1 1
Incomplete or Missing Packaging 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 8 8
No Consequences Or Impact To Patient 5 5
Local Reaction 3 3
Foreign Body In Patient 3 3
Insufficient Information 2 2
Burn(s) 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-08-2022
3 American Contract Systems, Inc. II May-06-2022
4 Avid Medical, Inc. II Mar-19-2020
5 Integra LifeSciences Corp. II Mar-22-2022
6 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
7 Medline Industries Inc II Dec-10-2021
8 ROi CPS LLC II Nov-23-2022
9 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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