TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	10544	10544
Crack	1298	1298
Naturally Worn	943	943
Fracture	827	827
Device-Device Incompatibility	702	702
Material Twisted/Bent	337	337
Material Deformation	213	213
Scratched Material	204	204
Contamination /Decontamination Problem	191	191
Appropriate Term/Code Not Available	164	164
Material Integrity Problem	125	125
No Apparent Adverse Event	106	106
Mechanical Jam	98	98
Detachment of Device or Device Component	74	74
Adverse Event Without Identified Device or Use Problem	72	72
Unintended Movement	62	62
Component Missing	57	57
Loose or Intermittent Connection	52	52
Connection Problem	40	40
Insufficient Information	39	39
Entrapment of Device	38	38
Failure to Disconnect	34	34
Illegible Information	33	33
Material Fragmentation	30	30
Disassembly	28	28
Mechanical Problem	28	28
Difficult to Remove	24	24
Physical Resistance/Sticking	24	24
Device Contamination with Chemical or Other Material	22	22
Material Discolored	21	21
Dull, Blunt	16	16
Detachment Of Device Component	16	16
Device Slipped	14	14
Device Operates Differently Than Expected	14	14
Fitting Problem	13	13
Bent	12	12
Corroded	11	11
Manufacturing, Packaging or Shipping Problem	11	11
Structural Problem	9	9
Use of Device Problem	9	9
Device Damaged by Another Device	8	8
Compatibility Problem	7	7
Device Dislodged or Dislocated	7	7
Device Reprocessing Problem	7	7
Off-Label Use	6	6
Defective Device	6	6
Deformation Due to Compressive Stress	5	5
Improper or Incorrect Procedure or Method	5	5
Device Issue	5	5
Device Damaged Prior to Use	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7243	7243
No Consequences Or Impact To Patient	4314	4314
No Information	1154	1154
No Known Impact Or Consequence To Patient	963	963
Insufficient Information	641	641
No Code Available	214	214
No Patient Involvement	131	131
Not Applicable	110	110
Foreign Body In Patient	56	56
Device Embedded In Tissue or Plaque	24	24
Pain	8	8
Unspecified Infection	7	7
Injury	6	6
Failure of Implant	4	4
Bone Fracture(s)	3	3
Sedation	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Inadequate Osseointegration	2	2
Reaction	2	2
Patient Problem/Medical Problem	1	1
Limited Mobility Of The Implanted Joint	1	1
Joint Disorder	1	1
Unspecified Musculoskeletal problem	1	1
Hematoma	1	1
Osteopenia/ Osteoporosis	1	1
Ossification	1	1
Foreign Body Reaction	1	1
Oversedation	1	1
Needle Stick/Puncture	1	1
Thrombosis	1	1
Host-Tissue Reaction	1	1
Non-union Bone Fracture	1	1
Tissue Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Encore Medical, Lp	II	Mar-08-2017
2	Enztec Limited	II	Jan-24-2020
3	Exactech, Inc.	II	Jun-30-2023
4	Exactech, Inc.	II	Sep-10-2019
5	Greatbatch Medical	I	Nov-29-2016
6	Stryker Howmedica Osteonics Corp.	II	Oct-07-2016
7	XTANT Medical	II	Jul-04-2020
8	Zimmer Biomet, Inc.	II	Feb-14-2018