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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device electrode, depth
Product CodeGZL
Regulation Number 882.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ALPHA OMEGA ENGINEERING LTD,
  SUBSTANTIALLY EQUIVALENT 1
ALPHA OMEGA ENGINEERING LTD.
  SUBSTANTIALLY EQUIVALENT 3
DIXI MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON
  SUBSTANTIALLY EQUIVALENT 1
NEUROONE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2019 13 13
2020 24 24
2021 13 13
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 8 8
Material Twisted/Bent 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Material Integrity Problem 5 5
Break 5 5
Flaked 3 3
Defective Device 3 3
Defective Component 2 2
Fracture 2 2
Material Fragmentation 2 2
Off-Label Use 2 2
Positioning Problem 2 2
Temperature Problem 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Inaccurate Information 1 1
Material Protrusion/Extrusion 1 1
Output Problem 1 1
Difficult to Remove 1 1
Self-Activation or Keying 1 1
Positioning Failure 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Device Difficult to Setup or Prepare 1 1
Signal Artifact/Noise 1 1
Inadequate or Insufficient Training 1 1
Improper or Incorrect Procedure or Method 1 1
Malposition of Device 1 1
Device Contamination with Chemical or Other Material 1 1
Incorrect Device Or Component Shipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
Foreign Body In Patient 14 14
No Clinical Signs, Symptoms or Conditions 8 8
Intracranial Hemorrhage 6 6
No Consequences Or Impact To Patient 2 2
Hemorrhage/Bleeding 2 2
Paresthesia 2 2
Insufficient Information 1 1
Not Applicable 1 1
Speech Disorder 1 1
Dyskinesia 1 1
Death 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Aug-28-2019
2 Ad-Tech Medical Instrument Corporation II Aug-26-2019
3 Ad-Tech Medical Instrument Corporation II Aug-06-2019
4 Alpha Omega Engineering I May-06-2019
5 DIXI MEDICAL USA II Jan-28-2022
6 FHC, Inc. II Jul-08-2020
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