TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5314	5314
Material Twisted/Bent	2623	2623
Device-Device Incompatibility	1477	1477
Fracture	1001	1001
Material Deformation	758	758
Naturally Worn	688	688
Calibration Problem	253	253
Material Integrity Problem	237	237
Contamination /Decontamination Problem	216	216
Dull, Blunt	202	202
Appropriate Term/Code Not Available	194	194
Material Fragmentation	133	133
Entrapment of Device	132	132
Crack	129	129
Mechanical Jam	107	107
Mechanical Problem	106	106
Detachment of Device or Device Component	81	81
Device Contamination with Chemical or Other Material	73	73
Compatibility Problem	69	69
Connection Problem	63	63
Bent	61	61
Device Operates Differently Than Expected	52	52
Use of Device Problem	47	47
Peeled/Delaminated	39	39
Unintended Movement	39	39
Packaging Problem	35	35
Physical Resistance/Sticking	35	35
Component Missing	34	34
Difficult to Remove	33	33
Adverse Event Without Identified Device or Use Problem	31	31
Device Slipped	28	28
No Apparent Adverse Event	26	26
Defective Device	26	26
Loose or Intermittent Connection	25	25
Failure To Adhere Or Bond	24	24
Detachment Of Device Component	21	21
Fitting Problem	20	20
Delivered as Unsterile Product	19	19
Material Separation	18	23
Scratched Material	17	17
Corroded	16	16
Insufficient Information	15	15
Illegible Information	14	14
Disassembly	13	13
Device Damaged Prior to Use	12	12
Structural Problem	10	10
Failure to Calibrate	9	9
Material Disintegration	9	9
Device Difficult to Setup or Prepare	9	9
Material Split, Cut or Torn	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6212	6217
No Consequences Or Impact To Patient	2698	2698
No Known Impact Or Consequence To Patient	1512	1512
No Patient Involvement	1083	1083
Insufficient Information	491	491
No Information	360	360
No Code Available	353	353
Foreign Body In Patient	335	335
Not Applicable	191	191
Device Embedded In Tissue or Plaque	174	174
Injury	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Patient Problem/Medical Problem	17	17
Failure of Implant	14	14
Unspecified Tissue Injury	9	9
Blood Loss	5	5
Hemorrhage/Bleeding	5	5
Pain	4	4
Bone Fracture(s)	3	3
Local Reaction	3	3
Sedation	3	3
Perforation of Vessels	3	3
Unspecified Infection	2	2
Skull Fracture	2	2
Exsanguination	2	2
Perforation	2	2
Laceration(s)	2	2
Spinal Cord Injury	2	2
Impaired Healing	1	1
Skin Inflammation/ Irritation	1	1
Foreign Body Reaction	1	1
Ossification	1	1
Irritation	1	1
Paralysis	1	1
Nerve Damage	1	1
Non-union Bone Fracture	1	1
Dysphagia/ Odynophagia	1	1
Joint Laxity	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Jul-19-2022
2	Flower Orthopedics Corporation	II	Jun-01-2021
3	Synthes (USA) Products LLC	II	May-28-2024
4	Synthes (USA) Products LLC	II	May-23-2018
5	Trilliant Surgical, LLC	II	Jan-10-2020
6	Zimmer Biomet, Inc.	II	Jul-04-2019