TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1354	1354
Device-Device Incompatibility	378	378
Material Twisted/Bent	228	228
Material Deformation	182	182
Naturally Worn	155	155
Fracture	133	133
Mechanical Jam	71	71
Crack	63	63
Appropriate Term/Code Not Available	53	53
Bent	45	45
Material Fragmentation	41	41
Material Integrity Problem	30	30
Device Operates Differently Than Expected	23	23
Scratched Material	20	20
Entrapment of Device	20	20
Difficult to Remove	19	19
Mechanical Problem	19	19
Adverse Event Without Identified Device or Use Problem	18	18
Dull, Blunt	17	17
Physical Resistance/Sticking	15	15
Corroded	14	14
Component Missing	13	13
Detachment of Device or Device Component	13	13
No Apparent Adverse Event	12	12
Loose or Intermittent Connection	12	12
Contamination /Decontamination Problem	11	11
Fitting Problem	10	10
Metal Shedding Debris	9	9
Connection Problem	9	9
Device Slipped	6	6
Device Damaged by Another Device	6	6
Insufficient Information	6	6
Illegible Information	6	6
Use of Device Problem	5	5
Unintended Movement	5	5
Device Issue	5	5
Defective Device	4	4
Structural Problem	4	4
Disassembly	4	4
Difficult to Open or Close	4	4
Detachment Of Device Component	3	3
Device Difficult to Maintain	3	3
Difficult to Insert	3	3
Failure to Align	3	3
Failure to Cut	3	3
Mechanics Altered	2	2
Device Handling Problem	2	2
Sticking	2	2
Device Damaged Prior to Use	2	2
Peeled/Delaminated	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1114	1114
No Consequences Or Impact To Patient	713	713
No Known Impact Or Consequence To Patient	270	270
No Information	159	159
No Code Available	143	143
Insufficient Information	105	105
No Patient Involvement	71	71
Not Applicable	42	42
Sedation	35	35
Device Embedded In Tissue or Plaque	32	32
Foreign Body In Patient	21	21
Failure of Implant	11	11
Bone Fracture(s)	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Blood Loss	5	5
Injury	4	4
Pain	4	4
Unspecified Infection	3	3
Discomfort	3	3
Non-union Bone Fracture	3	3
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
Tissue Damage	2	2
Cerebrospinal Fluid Leakage	2	2
Impaired Healing	1	1
Therapeutic Response, Increased	1	1
Joint Dislocation	1	1
Rheumatoid Arthritis	1	1
Fall	1	1
Therapeutic Response, Decreased	1	1
Arthritis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Dec-28-2010
2	Innomed, Inc.	II	May-01-2024
3	Stryker Howmedica Osteonics Corp.	II	Apr-27-2010
4	Synthes, Inc.	II	Apr-25-2018