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	8274	8287
Crack	990	993
Naturally Worn	901	905
Device-Device Incompatibility	817	820
Fracture	610	614
Material Deformation	391	392
Material Twisted/Bent	279	279
Contamination /Decontamination Problem	216	216
Scratched Material	161	161
No Apparent Adverse Event	151	151
Material Integrity Problem	141	141
Mechanical Jam	84	84
Unintended Movement	74	74
Detachment of Device or Device Component	65	65
Adverse Event Without Identified Device or Use Problem	58	59
Illegible Information	39	39
Entrapment of Device	32	32
Mechanical Problem	22	22
Failure to Disconnect	20	20
Material Discolored	17	18
Manufacturing, Packaging or Shipping Problem	16	16
Component Missing	15	15
Material Fragmentation	13	13
Device Slipped	12	12
Compatibility Problem	11	11
Loose or Intermittent Connection	11	11
Difficult to Remove	10	11
Physical Resistance/Sticking	9	10
Structural Problem	9	10
Improper or Incorrect Procedure or Method	8	8
Off-Label Use	7	7
Use of Device Problem	6	6
Corroded	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	4
Connection Problem	3	3
Nonstandard Device	3	3
Material Separation	3	3
Flaked	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Mechanics Altered	2	2
Dull, Blunt	2	2
Fitting Problem	2	2
Premature Separation	1	1
Osseointegration Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9184	9204
Insufficient Information	1169	1173
No Consequences Or Impact To Patient	1169	1169
No Code Available	162	162
No Known Impact Or Consequence To Patient	67	67
No Patient Involvement	40	40
Foreign Body In Patient	34	34
Not Applicable	21	21
Pain	5	5
Device Embedded In Tissue or Plaque	4	4
Unspecified Infection	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Failure of Implant	3	3
Bone Fracture(s)	3	3
No Information	2	2
Metal Related Pathology	1	1
Hematoma	1	1
Osteopenia/ Osteoporosis	1	1
Needle Stick/Puncture	1	1
Nerve Damage	1	1
Scar Tissue	1	1
Unspecified Tissue Injury	1	1