TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	840	840
Device-Device Incompatibility	367	367
Material Twisted/Bent	207	207
Material Deformation	161	161
Naturally Worn	142	142
Fracture	89	89
Mechanical Jam	56	56
Crack	51	51
Material Integrity Problem	28	28
Scratched Material	19	19
Entrapment of Device	17	17
Mechanical Problem	17	17
Physical Resistance/Sticking	14	14
Corroded	13	13
Adverse Event Without Identified Device or Use Problem	13	13
No Apparent Adverse Event	12	12
Contamination /Decontamination Problem	11	11
Detachment of Device or Device Component	9	9
Component Missing	9	9
Appropriate Term/Code Not Available	8	8
Difficult to Remove	8	8
Device Slipped	6	6
Illegible Information	6	6
Material Fragmentation	5	5
Use of Device Problem	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
Failure to Cut	3	3
Difficult to Insert	3	3
Loose or Intermittent Connection	3	3
Dull, Blunt	3	3
Device Damaged by Another Device	2	2
Mechanics Altered	2	2
Device Handling Problem	2	2
Device Damaged Prior to Use	2	2
Connection Problem	2	2
Degraded	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Advance	1	1
Human-Device Interface Problem	1	1
Activation Problem	1	1
Output Problem	1	1
Off-Label Use	1	1
Improper or Incorrect Procedure or Method	1	1
Activation, Positioning or Separation Problem	1	1
Unintended Collision	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1112	1112
No Consequences Or Impact To Patient	453	453
Insufficient Information	105	105
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	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Failure of Implant	6	6
Bone Fracture(s)	6	6
No Information	4	4
Blood Loss	4	4
Injury	3	3
Pain	3	3
Unspecified Infection	2	2
Patient Problem/Medical Problem	2	2
Muscle Weakness	2	2
Unspecified Nervous System Problem	2	2
Seroma	2	2
Numbness	2	2
Unspecified Tissue Injury	2	2
Cerebrospinal Fluid Leakage	2	2
Rheumatoid Arthritis	1	1
Discomfort	1	1
Therapeutic Response, Decreased	1	1
Device Embedded In Tissue or Plaque	1	1

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