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	27	27
Break	13	13
Unintended Movement	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Detachment of Device or Device Component	4	4
Mechanical Jam	3	3
Patient Device Interaction Problem	3	3
Positioning Problem	2	2
Difficult to Advance	2	2
Difficult to Remove	2	2
Crack	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Migration or Expulsion of Device	2	2
Difficult To Position	1	1
Device Maintenance Issue	1	1
Material Fragmentation	1	1
Contamination	1	1
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
Material Twisted/Bent	1	1
Scratched Material	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	31	31
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
Insufficient Information	2	2
Malunion of Bone	1	1
Unspecified Tissue Injury	1	1
No 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