TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	816	816
Device-Device Incompatibility	353	353
Material Twisted/Bent	203	203
Material Deformation	151	151
Naturally Worn	141	141
Fracture	88	88
Mechanical Jam	55	55
Crack	51	51
Material Integrity Problem	28	28
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
No Apparent Adverse Event	11	11
Component Missing	9	9
Detachment of Device or Device Component	8	8
Difficult to Remove	8	8
Appropriate Term/Code Not Available	8	8
Illegible Information	6	6
Device Slipped	6	6
Use of Device Problem	5	5
Material Fragmentation	5	5
Difficult to Open or Close	4	4
Structural Problem	4	4
Defective Device	4	4
Unintended Movement	4	4
Device Difficult to Maintain	3	3
Dull, Blunt	3	3
Difficult to Insert	3	3
Loose or Intermittent Connection	3	3
Device Damaged Prior to Use	2	2
Failure to Cut	2	2
Connection Problem	2	2
Device Damaged by Another Device	2	2
Mechanics Altered	2	2
Device Handling Problem	2	2
Activation Problem	1	1
Output Problem	1	1
Positioning Problem	1	1
Human-Device Interface Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Activation, Positioning or Separation Problem	1	1
Failure to Advance	1	1
Unintended Collision	1	1
Off-Label Use	1	1
Improper or Incorrect Procedure or Method	1	1
Degraded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1080	1080
No Consequences Or Impact To Patient	453	453
Insufficient Information	87	87
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