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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurosurgical nerve locator
Regulation Description Surgical nerve stimulator/locator.
Definition To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Product CodePDQ
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAGSTIM COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
NEURALYTIX
  SUBSTANTIALLY EQUIVALENT 1
NEURALYTIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEGUARD S.A.
  SUBSTANTIALLY EQUIVALENT 2
TEDAN SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 10 10
2022 16 17
2023 9 9
2024 4 4
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Fracture 5 5
Break 4 4
Failure to Deliver Shock/Stimulation 4 4
Communication or Transmission Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Inappropriate/Inadequate Shock/Stimulation 2 2
Display or Visual Feedback Problem 2 2
Signal Artifact/Noise 1 1
Circuit Failure 1 1
False Negative Result 1 1
Crack 1 2
Device Damaged Prior to Use 1 2
Patient-Device Incompatibility 1 1
No Audible Alarm 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Insufficient Device Problem Information 1 1
Imprecise or Erratic Results 1 2
Audible Prompt/Feedback Problem 1 1
Computer Operating System Problem 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Power Problem 1 1
Electromagnetic Interference 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 26
Insufficient Information 5 5
Foreign Body In Patient 3 3
Nerve Damage 2 2
Edema 1 1
Burn(s) 1 1
Paralysis 1 1
Numbness 1 1
Anaphylactic Shock 1 1
Convulsion/Seizure 1 1
Dysgeusia 1 1
Spinal Cord Injury 1 1
Nervous System Injury 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1

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