TPLC - Total Product Life Cycle

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Device	bit, surgical
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	GFG
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	242	244
Fracture	173	174
Material Fragmentation	31	31
Entrapment of Device	16	16
Failure to Cut	15	15
Mechanical Jam	11	11
Material Deformation	8	8
Device-Device Incompatibility	7	7
Material Twisted/Bent	6	6
Contamination /Decontamination Problem	5	5
Delivered as Unsterile Product	5	5
Residue After Decontamination	5	5
Physical Resistance/Sticking	4	4
Insufficient Information	4	4
Detachment of Device or Device Component	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Material Integrity Problem	2	2
Use of Device Problem	2	2
Component Missing	2	2
Difficult to Open or Close	2	2
Firing Problem	2	2
Unstable	1	1
Material Split, Cut or Torn	1	1
Mechanical Problem	1	3
Crack	1	1
Device Markings/Labelling Problem	1	1
Material Erosion	1	1
Difficult to Remove	1	1
Scratched Material	1	1
Positioning Failure	1	1
Material Discolored	1	1
Device Difficult to Setup or Prepare	1	1
Misassembled	1	1
Material Separation	1	1
Failure to Fire	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Failure to Cycle	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	364	365
Insufficient Information	36	38
Foreign Body In Patient	30	30
Device Embedded In Tissue or Plaque	12	13
Metal Related Pathology	2	2
Failure of Implant	1	1
Perforation	1	1
Unspecified Tissue Injury	1	1