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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological tray
Regulation Description Microsurgical instrument.
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 4 4

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 5 5
Burn(s) 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Avid Medical, Inc. II Mar-19-2020
3 Customed, Inc II Apr-14-2016
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