TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	792	792
Device-Device Incompatibility	338	338
Material Twisted/Bent	199	199
Material Deformation	151	151
Naturally Worn	137	137
Fracture	87	87
Mechanical Jam	55	55
Crack	49	49
Material Integrity Problem	26	26
Scratched Material	18	18
Mechanical Problem	17	17
Entrapment of Device	16	16
Physical Resistance/Sticking	14	14
Adverse Event Without Identified Device or Use Problem	13	13
Corroded	13	13
Contamination /Decontamination Problem	11	11
Component Missing	9	9
No Apparent Adverse Event	9	9
Appropriate Term/Code Not Available	8	8
Difficult to Remove	8	8
Detachment of Device or Device Component	8	8
Device Slipped	6	6
Illegible Information	6	6
Use of Device Problem	5	5
Material Fragmentation	5	5
Structural Problem	4	4
Difficult to Open or Close	4	4
Defective Device	4	4
Unintended Movement	4	4
Device Difficult to Maintain	3	3
Difficult to Insert	3	3
Loose or Intermittent Connection	3	3
Dull, Blunt	3	3
Device Damaged Prior to Use	2	2
Mechanics Altered	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Connection Problem	2	2
Device Handling Problem	2	2
Output Problem	1	1
Positioning Problem	1	1
Activation Problem	1	1
Activation, Positioning or Separation Problem	1	1
Failure to Advance	1	1
Human-Device Interface Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Unintended Collision	1	1
Off-Label Use	1	1
Degraded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1042	1042
No Consequences Or Impact To Patient	453	453
Insufficient Information	78	78
No Code Available	76	76
Not Applicable	27	27
No Patient Involvement	26	26
No Known Impact Or Consequence To Patient	19	19
Foreign Body In Patient	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Bone Fracture(s)	6	6
Failure of Implant	6	6
Blood Loss	4	4
No Information	4	4
Pain	3	3
Injury	3	3
Numbness	2	2
Patient Problem/Medical Problem	2	2
Seroma	2	2
Cerebrospinal Fluid Leakage	2	2
Unspecified Infection	2	2
Muscle Weakness	2	2
Unspecified Nervous System Problem	2	2
Unspecified Tissue Injury	2	2
Rheumatoid Arthritis	1	1
Device Embedded In Tissue or Plaque	1	1
Therapeutic Response, Decreased	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Innomed, Inc.	II	May-01-2024