TPLC - Total Product Life Cycle

show TPLC since

Device	passer
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWQ
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	276	278
Detachment of Device or Device Component	53	53
Material Fragmentation	15	15
Mechanical Jam	13	13
Mechanical Problem	12	12
Fracture	11	11
Physical Resistance/Sticking	10	10
Material Deformation	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Difficult to Open or Close	7	7
Failure to Cycle	4	4
Device Dislodged or Dislocated	4	4
Material Integrity Problem	4	4
Misassembled	4	4
Flaked	3	3
Firing Problem	3	3
Insufficient Information	3	3
Expiration Date Error	2	2
Failure to Fire	2	2
No Apparent Adverse Event	2	2
Device Damaged Prior to Use	2	2
Activation Problem	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Unstable	2	2
Use of Device Problem	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Difficult to Insert	1	1
Difficult to Remove	1	1
Delivered as Unsterile Product	1	1
Failure to Capture	1	1
Retraction Problem	1	1
Material Separation	1	1
Migration	1	1
Unintended Movement	1	1
Failure to Advance	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Inaccurate Information	1	1
Device Contaminated During Manufacture or Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	393	395
Foreign Body In Patient	16	16
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cardiac Arrest	2	2
Hemorrhage/Bleeding	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Infection	1	1
Failure of Implant	1	1
Perforation	1	1
Rupture	1	1
Chills	1	1
Loss of Range of Motion	1	1
Laceration(s)	1	1