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	7320	7320
Crack	911	911
Naturally Worn	900	900
Device-Device Incompatibility	692	692
Fracture	546	546
Material Twisted/Bent	279	279
Material Deformation	235	235
Contamination /Decontamination Problem	200	200
Scratched Material	148	148
Material Integrity Problem	130	130
No Apparent Adverse Event	120	120
Mechanical Jam	75	75
Unintended Movement	67	67
Adverse Event Without Identified Device or Use Problem	58	58
Detachment of Device or Device Component	57	57
Illegible Information	39	39
Entrapment of Device	32	32
Failure to Disconnect	19	19
Mechanical Problem	18	18
Material Discolored	17	17
Manufacturing, Packaging or Shipping Problem	16	16
Component Missing	15	15
Material Fragmentation	11	11
Loose or Intermittent Connection	11	11
Device Slipped	11	11
Difficult to Remove	9	9
Physical Resistance/Sticking	9	9
Structural Problem	9	9
Compatibility Problem	8	8
Off-Label Use	7	7
Improper or Incorrect Procedure or Method	7	7
Corroded	6	6
Use of Device Problem	6	6
Appropriate Term/Code Not Available	6	6
Deformation Due to Compressive Stress	5	5
Insufficient Information	4	4
Solder Joint Fracture	4	4
Difficult to Insert	3	3
Nonstandard Device	3	3
Material Separation	3	3
Connection Problem	2	2
Flaked	2	2
Dull, Blunt	2	2
Mechanics Altered	2	2
Device Damaged by Another Device	2	2
Failure to Cut	2	2
Fitting Problem	2	2
Device Handling Problem	1	1
Packaging Problem	1	1
Missing Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7974	7974
No Consequences Or Impact To Patient	1169	1169
Insufficient Information	1048	1048
No Code Available	162	162
No Known Impact Or Consequence To Patient	67	67
No Patient Involvement	40	40
Foreign Body In Patient	30	30
Not Applicable	21	21
Pain	4	4
Unspecified Infection	3	3
Failure of Implant	3	3
Device Embedded In Tissue or Plaque	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Information	2	2
Bone Fracture(s)	2	2
Hematoma	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Unspecified Tissue Injury	1	1