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
Defective Device	5	5
Material Fragmentation	5	5
Difficult to Remove	5	5
Insufficient Information	4	4
Malposition of Device	4	4
Flaked	3	3
Material Protrusion/Extrusion	3	3
Fracture	3	3
Defective Component	3	3
Device Operates Differently Than Expected	2	2
Signal Artifact/Noise	2	2
Off-Label Use	2	2
Inadequacy of Device Shape and/or Size	2	2
Sticking	2	2
Positioning Problem	2	2
Disconnection	2	2
Entrapment of Device	1	1
Impedance Problem	1	1
Separation Problem	1	1
Noise, Audible	1	1
Device Slipped	1	1
Fluid/Blood Leak	1	1
Temperature Problem	1	1
Detachment of Device or Device Component	1	1
Output Problem	1	1
Incorrect Device Or Component Shipped	1	1
Device Contamination with Chemical or Other Material	1	1
Image Display Error/Artifact	1	1
Unintended Movement	1	1
Human Factors Issue	1	1
Inaccurate Information	1	1
Device Damaged by Another Device	1	1
Positioning Failure	1	1
Failure to Power Up	1	1
Inadequate or Insufficient Training	1	1
Separation Failure	1	1
Appropriate Term/Code Not Available	1	1
Metal Shedding Debris	1	1
Loss of or Failure to Bond	1	1
Device Difficult to Setup or Prepare	1	1
No Display/Image	1	1
Structural Problem	1	1
Use of Device Problem	1	1
Self-Activation or Keying	1	1
High impedance	1	1
Delivered as Unsterile Product	1	1
Unintended System Motion	1	1
Bent	1	1
Improper or Incorrect Procedure or Method	1	1
Energy Output Problem	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