TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	994	994
Material Deformation	407	407
Mechanical Jam	106	106
Device-Device Incompatibility	70	70
Incorrect Measurement	41	41
Use of Device Problem	36	36
Material Twisted/Bent	32	32
Fracture	27	27
Mechanical Problem	22	22
Material Integrity Problem	20	20
Detachment of Device or Device Component	19	19
Naturally Worn	15	15
Illegible Information	12	12
Component Missing	11	11
Device Slipped	9	9
Appropriate Term/Code Not Available	8	8
Crack	7	7
Material Discolored	7	7
No Apparent Adverse Event	7	7
Entrapment of Device	6	6
Degraded	4	4
Defective Device	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Unintended Movement	2	2
Separation Failure	2	2
Output Problem	1	1
Contamination /Decontamination Problem	1	1
Device Markings/Labelling Problem	1	1
Device Damaged by Another Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Disconnection	1	1
Misassembled	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Material Fragmentation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Component Misassembled	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1196	1196
No Consequences Or Impact To Patient	269	269
No Patient Involvement	208	208
Insufficient Information	49	49
No Code Available	11	11
No Known Impact Or Consequence To Patient	10	10
Foreign Body In Patient	9	9
Not Applicable	2	2
No Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Injury	1	1
Bone Fracture(s)	1	1
Failure of Implant	1	1
Laceration(s)	1	1
Pneumothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Biomet, Inc.	II	Jul-04-2019