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TPLC
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Device
neurosurgical nerve locator
Definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Product Code
PDQ
Regulation Number
874.1820
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALPHATEC SPINE, INC
SUBSTANTIALLY EQUIVALENT
1
ALPHATEC SPINE, INC.
SUBSTANTIALLY EQUIVALENT
2
BOSTON ENDO SURGICAL TECH,
SUBSTANTIALLY EQUIVALENT
1
MAGSTIM COMPANY LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL, SARL
SUBSTANTIALLY EQUIVALENT
1
SPINE GUARD S.A.
SUBSTANTIALLY EQUIVALENT
1
SPINEGUARD, S.A.
SUBSTANTIALLY EQUIVALENT
1
SURGENTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
9
9
2021
10
10
2022
16
16
2023
9
9
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
10
10
Break
6
6
Adverse Event Without Identified Device or Use Problem
6
6
Fracture
5
5
Device Alarm System
5
5
Failure to Deliver Shock/Stimulation
3
3
Crack
2
2
Deflation Problem
2
2
Display or Visual Feedback Problem
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Failure to Read Input Signal
2
2
Patient-Device Incompatibility
2
2
Difficult to Remove
2
2
Power Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Audible Prompt/Feedback Problem
1
1
Erratic Results
1
1
Communication or Transmission Problem
1
1
Computer Operating System Problem
1
1
Detachment of Device or Device Component
1
1
Use of Device Problem
1
1
Device Damaged Prior to Use
1
1
Electromagnetic Interference
1
1
Entrapment of Device
1
1
False Negative Result
1
1
No Audible Alarm
1
1
Signal Artifact/Noise
1
1
Circuit Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
No Consequences Or Impact To Patient
6
6
Insufficient Information
4
4
Foreign Body In Patient
3
3
Paralysis
2
2
Nerve Damage
2
2
Burn, Thermal
2
2
Nerve Proximity Nos (Not Otherwise Specified)
2
2
No Known Impact Or Consequence To Patient
2
2
Full thickness (Third Degree) Burn
2
2
Device Embedded In Tissue or Plaque
2
2
No Code Available
1
1
Convulsion/Seizure
1
1
Dysgeusia
1
1
Pain
1
1
Extubate
1
1
Numbness
1
1
Spinal Cord Injury
1
1
Anaphylactic Shock
1
1
Awareness during Anaesthesia
1
1
Edema
1
1
Muscle Spasm(s)
1
1
Nervous System Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
NuVasive Inc
II
Jul-22-2020
2
The Magstim Company Limited
II
Aug-25-2020
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