TPLC - Total Product Life Cycle

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Device	impactor
Regulation Description	Orthopedic manual surgical instrument.
Product Code	HWA
Regulation Number	888.4540
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7901	7914
Device-Device Incompatibility	886	889
Crack	881	884
Naturally Worn	864	868
Fracture	578	582
Material Deformation	521	522
Contamination /Decontamination Problem	213	213
No Apparent Adverse Event	186	186
Material Twisted/Bent	146	146
Material Integrity Problem	138	138
Scratched Material	136	136
Unintended Movement	81	81
Mechanical Jam	77	77
Detachment of Device or Device Component	73	73
Adverse Event Without Identified Device or Use Problem	43	44
Illegible Information	37	37
Entrapment of Device	29	29
Failure to Disconnect	20	20
Mechanical Problem	20	20
Manufacturing, Packaging or Shipping Problem	16	16
Material Fragmentation	12	12
Compatibility Problem	11	11
Material Discolored	11	12
Improper or Incorrect Procedure or Method	8	8
Structural Problem	8	9
Corroded	7	7
Difficult to Remove	6	7
Deformation Due to Compressive Stress	5	5
Use of Device Problem	4	4
Off-Label Use	4	4
Difficult to Insert	3	4
Solder Joint Fracture	3	3
Material Separation	3	3
Physical Resistance/Sticking	3	4
Appropriate Term/Code Not Available	3	3
Nonstandard Device	3	3
Mechanics Altered	2	2
Flaked	2	2
Loose or Intermittent Connection	2	2
Device Slipped	2	2
Patient Device Interaction Problem	1	1
Positioning Failure	1	1
Device Difficult to Setup or Prepare	1	1
Component Missing	1	1
Dent in Material	1	1
Failure to Clean Adequately	1	1
Device Damaged by Another Device	1	1
Sharp Edges	1	1
Therapeutic or Diagnostic Output Failure	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10068	10088
Insufficient Information	1161	1165
Foreign Body In Patient	35	35
No Consequences Or Impact To Patient	5	5
No Known Impact Or Consequence To Patient	4	4
No Patient Involvement	4	4
Unspecified Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Failure of Implant	3	3
Pain	3	3
Bone Fracture(s)	1	1
Hematoma	1	1
Implant Pain	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Discomfort	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1