TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4053	4053
Material Twisted/Bent	2574	2574
Device-Device Incompatibility	1480	1480
Fracture	853	853
Material Deformation	627	627
Naturally Worn	574	574
Calibration Problem	255	255
Material Integrity Problem	231	231
Contamination /Decontamination Problem	192	192
Entrapment of Device	132	132
Crack	100	100
Mechanical Jam	96	96
Mechanical Problem	89	89
Detachment of Device or Device Component	79	79
Compatibility Problem	71	71
Material Fragmentation	62	62
Connection Problem	55	55
Appropriate Term/Code Not Available	45	45
Use of Device Problem	43	43
Unintended Movement	39	39
Packaging Problem	34	34
Physical Resistance/Sticking	32	32
Component Missing	27	27
No Apparent Adverse Event	27	27
Defective Device	27	27
Adverse Event Without Identified Device or Use Problem	26	26
Device Slipped	26	26
Material Separation	22	27
Device Contamination with Chemical or Other Material	20	20
Delivered as Unsterile Product	19	19
Difficult to Remove	16	16
Scratched Material	16	16
Corroded	15	15
Illegible Information	14	14
Loose or Intermittent Connection	13	13
Dull, Blunt	10	10
Failure to Calibrate	9	9
Electrical /Electronic Property Problem	9	9
Device Damaged Prior to Use	9	9
Device Difficult to Setup or Prepare	9	9
Degraded	8	8
Material Disintegration	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
Improper or Incorrect Procedure or Method	6	6
Material Split, Cut or Torn	6	6
Device Damaged by Another Device	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6578	6583
No Consequences Or Impact To Patient	1837	1837
No Patient Involvement	686	686
Insufficient Information	549	549
No Known Impact Or Consequence To Patient	506	506
Foreign Body In Patient	277	277
No Code Available	200	200
Device Embedded In Tissue or Plaque	95	95
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
Bone Fracture(s)	3	3
Blood Loss	3	3
Perforation of Vessels	3	3
Skull Fracture	2	2
Exsanguination	2	2
Perforation	2	2
Spinal Cord Injury	2	2
Unspecified Infection	1	1
Impaired Healing	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