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TPLC
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Device
manipulator, plunger-like joint
Product Code
LXM
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
ACTIVATOR METHODS INTERNATIONAL LTD.
SUBSTANTIALLY EQUIVALENT
1
NEURO SPINAL INNOVATION INC
SUBSTANTIALLY EQUIVALENT
1
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SPINAL ACOUSTICS, LLC
SUBSTANTIALLY EQUIVALENT
1
SPINALIGHT, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
3
3
2018
1
1
2020
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
2
2
Protective Measures Problem
1
1
Insufficient Information
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
2
2
No Known Impact Or Consequence To Patient
1
1
Dyspnea
1
1
Pain
1
1
Paralysis
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Advanced Orthogonal Equipment, Incorporated
II
Jul-25-2013
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