TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AD-TECH MEDICAL INSTRUMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
ALPHA OMEGA ENGINEERING LTD,
	SUBSTANTIALLY EQUIVALENT	1
ALPHA OMEGA ENGINEERING LTD.
	SUBSTANTIALLY EQUIVALENT	4
ALPHA OMEGA ENGINEERING, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ALPINE BIOMED APS
	SUBSTANTIALLY EQUIVALENT	1
BLACKROCK MICROSYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
DIXI MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
FHC, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICE NEUROSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	2
PMT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SENSOMEDICAL LABS LTD
	SUBSTANTIALLY EQUIVALENT	1
WE SENSE LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	28	28
Material Separation	11	11
Material Twisted/Bent	9	9
Material Integrity Problem	7	7
Break	7	7
Material Fragmentation	5	5
Difficult to Remove	5	5
Defective Device	5	5
Malposition of Device	4	4
Insufficient Information	4	4
Material Protrusion/Extrusion	3	3
Fracture	3	3
Defective Component	3	3
Flaked	3	3
Disconnection	2	2
Signal Artifact/Noise	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Operates Differently Than Expected	2	2
Off-Label Use	2	2
Sticking	2	2
Positioning Problem	2	2
Temperature Problem	1	1
Unintended Movement	1	1
Output Problem	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Separation Problem	1	1
Inaccurate Information	1	1
Inadequate or Insufficient Training	1	1
Use of Device Problem	1	1
Metal Shedding Debris	1	1
Improper or Incorrect Procedure or Method	1	1
Self-Activation or Keying	1	1
Device Damaged by Another Device	1	1
Device Contamination with Chemical or Other Material	1	1
Human Factors Issue	1	1
Impedance Problem	1	1
Incorrect Device Or Component Shipped	1	1
Device Slipped	1	1
Structural Problem	1	1
Separation Failure	1	1
Bent	1	1
Loss of or Failure to Bond	1	1
Positioning Failure	1	1
No Display/Image	1	1
Entrapment of Device	1	1
Fluid/Blood Leak	1	1
High impedance	1	1
Image Display Error/Artifact	1	1
Delivered as Unsterile Product	1	1
Unintended System Motion	1	1
Energy Output Problem	1	1
Failure to Power Up	1	1
Device Difficult to Setup or Prepare	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	38	38
Foreign Body In Patient	27	27
No Clinical Signs, Symptoms or Conditions	18	18
Insufficient Information	9	9
Intracranial Hemorrhage	9	9
Hemorrhage/Bleeding	7	7
Device Embedded In Tissue or Plaque	4	4
No Information	4	4
No Consequences Or Impact To Patient	3	3
Death	2	2
Hematoma	2	2
Paresthesia	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Code Available	1	1
Speech Disorder	1	1
Not Applicable	1	1
Bradycardia	1	1
Fatigue	1	1
Fever	1	1
Malaise	1	1
Dyskinesia	1	1
Fungal Infection	1	1
Confusion/ Disorientation	1	1
Hematuria	1	1
Hemorrhage, Subarachnoid	1	1
Hemorrhage, Subdural	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Memory Loss/Impairment	1	1
Muscle Spasm(s)	1	1
Paresis	1	1
Tissue Damage	1	1
Urinary Tract Infection	1	1
Dizziness	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	Ad-Tech Medical Instrument Corporation	II	Oct-21-2014
5	Alpha Omega Engineering	I	May-06-2019
6	Cyberkinetics Neurotechnology Systems, Inc.	II	Jul-07-2009
7	DIXI MEDICAL USA	II	Jan-28-2022
8	FHC, Inc.	II	Jul-08-2020
9	FHC, Inc.	II	Mar-16-2010