TPLC - Total Product Life Cycle

show TPLC since

Device	component, traction, invasive
Product Code	JEC
Regulation Number	888.3040
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANJON HOLDINGS LLC
	SUBSTANTIALLY EQUIVALENT	1
ANJON HOLDINGS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARBUTUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
HAND BIOMECHANICS LAB, INC.
	SUBSTANTIALLY EQUIVALENT	1
SINTEA BIOTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
	SUBSTANTIALLY EQUIVALENT	1
VIRAK ORTHOPEDIC RESEARCH, LLC
	SUBSTANTIALLY EQUIVALENT	1
VIRAK ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	25	25
Break	11	11
Unintended Movement	5	5
Detachment of Device or Device Component	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Mechanical Jam	3	3
Patient Device Interaction Problem	3	3
Positioning Problem	2	2
Difficult to Advance	2	2
Mechanical Problem	2	2
Migration or Expulsion of Device	2	2
Loose or Intermittent Connection	2	2
Difficult to Remove	2	2
Material Too Rigid or Stiff	1	1
Device Slipped	1	1
Defective Component	1	1
Component Missing	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Device Maintenance Issue	1	1
Contamination	1	1
Material Fragmentation	1	1
Difficult To Position	1	1
Material Twisted/Bent	1	1
Therapeutic or Diagnostic Output Failure	1	1
Migration	1	1
Physical Resistance/Sticking	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	30	30
No Code Available	11	11
No Known Impact Or Consequence To Patient	6	6
Failure of Implant	5	5
Injury	5	5
Bacterial Infection	3	3
No Patient Involvement	3	3
No Consequences Or Impact To Patient	2	2
No Information	1	1
Malunion of Bone	1	1
Unspecified Tissue Injury	1	1
Insufficient Information	1	1
Death	1	1
Bone Fracture(s)	1	1
Numbness	1	1
Pseudoaneurysm	1	1
Unspecified Infection	1	1
Internal Organ Perforation	1	1
Pain	1	1
Burning Sensation	1	1