TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3855	3855
Material Twisted/Bent	2465	2465
Device-Device Incompatibility	1419	1419
Fracture	808	808
Material Deformation	605	605
Naturally Worn	563	563
Calibration Problem	251	251
Material Integrity Problem	221	221
Contamination /Decontamination Problem	187	187
Entrapment of Device	122	122
Crack	95	95
Mechanical Jam	94	94
Mechanical Problem	87	87
Detachment of Device or Device Component	73	73
Compatibility Problem	69	69
Material Fragmentation	60	60
Connection Problem	55	55
Appropriate Term/Code Not Available	44	44
Use of Device Problem	43	43
Unintended Movement	38	38
Packaging Problem	34	34
Physical Resistance/Sticking	32	32
Component Missing	27	27
No Apparent Adverse Event	26	26
Adverse Event Without Identified Device or Use Problem	26	26
Defective Device	25	25
Device Slipped	22	22
Device Contamination with Chemical or Other Material	20	20
Delivered as Unsterile Product	19	19
Material Separation	17	22
Difficult to Remove	16	16
Scratched Material	16	16
Corroded	14	14
Illegible Information	14	14
Loose or Intermittent Connection	13	13
Dull, Blunt	10	10
Failure to Calibrate	9	9
Device Damaged Prior to Use	9	9
Device Difficult to Setup or Prepare	9	9
Electrical /Electronic Property Problem	8	8
Material Disintegration	7	7
Degraded	7	7
Fitting Problem	7	7
Noise, Audible	7	7
Structural Problem	7	7
Device Reprocessing Problem	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Material Split, Cut or Torn	6	6
Device Difficult to Maintain	6	6
Improper or Incorrect Procedure or Method	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6208	6213
No Consequences Or Impact To Patient	1837	1837
No Patient Involvement	686	686
No Known Impact Or Consequence To Patient	506	506
Insufficient Information	491	491
Foreign Body In Patient	263	263
No Code Available	200	200
Device Embedded In Tissue or Plaque	94	94
Not Applicable	87	87
No Information	79	79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Injury	21	21
Failure of Implant	9	9
Unspecified Tissue Injury	9	9
Patient Problem/Medical Problem	8	8
Hemorrhage/Bleeding	5	5
Pain	4	4
Blood Loss	3	3
Perforation of Vessels	3	3
Skull Fracture	2	2
Bone Fracture(s)	2	2
Exsanguination	2	2
Perforation	2	2
Spinal Cord Injury	2	2
Impaired Healing	1	1
Unspecified Infection	1	1
Skin Inflammation/ Irritation	1	1
Ossification	1	1
Paralysis	1	1
Nerve Damage	1	1
Laceration(s)	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	Trilliant Surgical, LLC	II	Jan-10-2020
5	Zimmer Biomet, Inc.	II	Jul-04-2019