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	307	307
Material Separation	42	42
Detachment of Device or Device Component	34	34
Mechanical Jam	25	25
Mechanical Problem	16	16
Physical Resistance/Sticking	12	12
Material Deformation	11	11
Fracture	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Material Fragmentation	8	8
Material Integrity Problem	7	7
Firing Problem	6	6
Insufficient Information	6	6
Material Split, Cut or Torn	5	5
Misassembled	5	5
Difficult to Open or Close	4	4
Device Dislodged or Dislocated	4	4
No Apparent Adverse Event	4	4
Ejection Problem	4	4
Device-Device Incompatibility	3	3
Nonstandard Device	3	3
Device Damaged Prior to Use	3	3
Device Fell	3	3
Failure to Fire	3	3
Flaked	2	2
Failure to Cycle	2	2
Failure to Advance	2	2
Activation Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Material Twisted/Bent	1	1
Problem with Sterilization	1	1
Use of Device Problem	1	1
Positioning Failure	1	1
Delivered as Unsterile Product	1	1
Solder Joint Fracture	1	1
Difficult to Insert	1	1
Failure to Capture	1	1
Difficult to Remove	1	1
Defective Device	1	1
Expiration Date Error	1	1
Unsealed Device Packaging	1	1
Migration	1	1
Unintended Movement	1	1
Difficult to Fold, Unfold or Collapse	1	1
Crack	1	1
Appropriate Term/Code Not Available	1	1
Grounding Malfunction	1	1
Melted	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	360	360
No Known Impact Or Consequence To Patient	91	91
No Consequences Or Impact To Patient	27	27
Foreign Body In Patient	17	17
No Information	12	12
Insufficient Information	7	7
No Patient Involvement	6	6
Injury	5	5
Device Embedded In Tissue or Plaque	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Hypersensitivity/Allergic reaction	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