TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	14308	14308
Dull, Blunt	3350	3350
Break	2311	2311
Naturally Worn	2241	2241
Corroded	1735	1735
Device-Device Incompatibility	773	773
Material Twisted/Bent	712	712
Adverse Event Without Identified Device or Use Problem	539	539
No Apparent Adverse Event	497	497
Material Deformation	376	376
Entrapment of Device	340	340
Appropriate Term/Code Not Available	327	327
Illegible Information	299	299
Crack	215	215
Contamination /Decontamination Problem	171	171
Fracture	144	144
Material Discolored	128	128
Material Fragmentation	93	93
Detachment of Device or Device Component	82	82
Scratched Material	82	82
Mechanical Jam	76	76
Device Contamination with Chemical or Other Material	50	50
Pitted	47	47
Loose or Intermittent Connection	45	45
Degraded	44	44
Component Missing	37	37
Device Operates Differently Than Expected	36	36
Device Contaminated During Manufacture or Shipping	33	33
Material Integrity Problem	32	32
Insufficient Information	28	28
Difficult to Insert	23	23
Physical Resistance/Sticking	23	23
Unintended Movement	21	21
Bent	20	20
Connection Problem	19	19
Improper or Incorrect Procedure or Method	18	18
Fitting Problem	15	15
Disassembly	15	15
Material Erosion	15	15
Use of Device Problem	13	13
Mechanical Problem	12	12
Difficult to Remove	10	10
Product Quality Problem	10	10
Structural Problem	9	9
Detachment Of Device Component	9	9
Peeled/Delaminated	9	9
Device Slipped	8	8
Device Disinfection Or Sterilization Issue	7	7
Difficult to Open or Close	7	7
Failure To Adhere Or Bond	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16152	16152
No Consequences Or Impact To Patient	4912	4912
No Information	1147	1147
Insufficient Information	1132	1132
No Known Impact Or Consequence To Patient	650	650
No Code Available	528	528
Foreign Body In Patient	393	393
No Patient Involvement	231	231
Not Applicable	218	218
Bone Fracture(s)	70	70
Device Embedded In Tissue or Plaque	69	69
Pain	36	36
Injury	31	31
Unspecified Infection	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Blood Loss	19	19
Limb Fracture	18	18
Unspecified Tissue Injury	17	17
Sedation	13	13
Non-union Bone Fracture	12	12
Failure of Implant	10	10
Septic Shock	5	5
Hemorrhage/Bleeding	4	4
Shock	4	4
Loss of Range of Motion	4	4
Hip Fracture	4	4
Tissue Damage	3	3
Post Operative Wound Infection	3	3
Low Blood Pressure/ Hypotension	3	3
Discomfort	3	3
Hematoma	2	2
Embolism	2	2
Nerve Damage	2	2
Patient Problem/Medical Problem	2	2
Fall	2	2
Impaired Healing	2	2
Deformity/ Disfigurement	1	1
Skin Tears	1	1
Swelling/ Edema	1	1
Perforation of Vessels	1	1
Pulmonary Embolism	1	1
Host-Tissue Reaction	1	1
Physical Entrapment	1	1
Bradycardia	1	1
Hyperextension	1	1
Laceration(s)	1	1
Burn(s)	1	1
Unspecified Nervous System Problem	1	1
Neurological Deficit/Dysfunction	1	1
Paresthesia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arthrex, Inc.	II	Nov-09-2018
2	Biomet, Inc.	II	May-26-2016
3	Cayenne Medical Inc.	II	Jul-25-2018
4	Encore Medical, Lp	II	Aug-31-2017
5	Synthes (USA) Products LLC	II	Mar-01-2024
6	Synthes (USA) Products LLC	II	Dec-15-2020
7	Synthes (USA) Products LLC	II	Mar-05-2018
8	Synthes (USA) Products LLC	II	Nov-23-2016
9	Synthes (USA) Products LLC	II	Nov-19-2016
10	Synthes (USA) Products LLC	II	Jun-06-2016
11	Synthes (USA) Products LLC	II	Jan-05-2016
12	T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.	II	Mar-20-2020
13	Zimmer, Inc.	II	Feb-06-2023