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	7556	7556
Crack	937	937
Naturally Worn	902	902
Device-Device Incompatibility	725	725
Fracture	553	553
Material Twisted/Bent	279	279
Material Deformation	273	273
Contamination /Decontamination Problem	202	202
Scratched Material	151	151
No Apparent Adverse Event	132	132
Material Integrity Problem	130	130
Mechanical Jam	76	76
Unintended Movement	70	70
Detachment of Device or Device Component	60	60
Adverse Event Without Identified Device or Use Problem	58	58
Illegible Information	39	39
Entrapment of Device	32	32
Failure to Disconnect	20	20
Mechanical Problem	20	20
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
Compatibility Problem	10	10
Difficult to Remove	9	9
Physical Resistance/Sticking	9	9
Structural Problem	9	9
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
Connection Problem	3	3
Difficult to Insert	3	3
Nonstandard Device	3	3
Material Separation	3	3
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	8200	8200
No Consequences Or Impact To Patient	1169	1169
Insufficient Information	1153	1153
No Code Available	162	162
No Known Impact Or Consequence To Patient	67	67
No Patient Involvement	40	40
Foreign Body In Patient	31	31
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