TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5857	5857
Naturally Worn	1605	1605
Device-Device Incompatibility	1319	1319
Scratched Material	1056	1056
Crack	930	930
Detachment of Device or Device Component	685	685
Fracture	510	510
Material Deformation	485	485
Material Twisted/Bent	412	412
Contamination /Decontamination Problem	312	312
Illegible Information	302	302
Material Integrity Problem	211	211
Mechanical Jam	167	167
Component Missing	155	155
Peeled/Delaminated	153	153
No Apparent Adverse Event	149	149
Appropriate Term/Code Not Available	149	149
Material Discolored	145	145
Adverse Event Without Identified Device or Use Problem	113	113
Insufficient Information	94	94
Unintended Movement	71	71
Entrapment of Device	69	69
Corroded	68	68
Incorrect Measurement	56	56
Use of Device Problem	55	55
Physical Resistance/Sticking	40	40
Failure to Cut	40	40
Material Fragmentation	39	39
Disassembly	34	34
Loose or Intermittent Connection	32	32
Difficult to Remove	27	27
Device Dislodged or Dislocated	27	27
Device Operates Differently Than Expected	26	26
Mechanical Problem	25	25
Structural Problem	23	23
Bent	23	23
Device Contamination With Biological Material	22	22
Dull, Blunt	21	21
Connection Problem	18	18
Fitting Problem	17	17
Compatibility Problem	15	15
Difficult to Insert	14	14
Improper or Incorrect Procedure or Method	13	13
Device Slipped	10	10
Loss of Osseointegration	10	10
Off-Label Use	10	10
Residue After Decontamination	10	10
Difficult to Open or Close	9	9
Separation Failure	9	9
Detachment Of Device Component	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7958	7958
No Consequences Or Impact To Patient	1901	1901
Insufficient Information	742	742
No Information	623	623
No Known Impact Or Consequence To Patient	545	545
No Code Available	182	182
No Patient Involvement	168	168
Not Applicable	86	86
Pain	55	55
Foreign Body In Patient	50	50
Reaction	35	35
Unspecified Infection	32	32
Device Embedded In Tissue or Plaque	28	28
Bone Fracture(s)	27	27
Sedation	21	21
Limb Fracture	9	9
Injury	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Joint Dislocation	8	8
Loss of Range of Motion	6	6
Impaired Healing	4	4
Physical Asymmetry	4	4
Tissue Damage	4	4
Joint Laxity	4	4
Osteolysis	4	4
Ambulation Difficulties	3	3
Unspecified Tissue Injury	3	3
Paresis	3	3
Discomfort	3	3
Cyst(s)	3	3
Muscle Weakness	3	3
Metal Related Pathology	3	3
Failure of Implant	3	3
Complaint, Ill-Defined	3	3
Neck Pain	2	2
Inflammation	2	2
Laceration(s)	2	2
Swelling/ Edema	2	2
Wound Dehiscence	2	2
Bruise/Contusion	2	2
Fever	1	1
Paralysis	1	1
Foreign Body Reaction	1	1
Blood Loss	1	1
Swelling	1	1
Synovitis	1	1
Adhesion(s)	1	1
Joint Swelling	1	1
Nerve Damage	1	1
Depression	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Feb-12-2018
2	Aesculap Implant Systems LLC	II	Jul-31-2012
3	Biomet Microfixation, LLC	II	May-12-2017
4	Biomet, Inc.	II	Jul-14-2015
5	Biomet, Inc.	II	Oct-16-2014
6	DePuy Orthopaedics, Inc.	II	Jul-20-2022
7	DePuy Orthopaedics, Inc.	II	Apr-09-2014
8	DePuy Orthopaedics, Inc.	II	Jun-07-2013
9	Encore Medical, Lp	II	Jul-27-2015
10	Integra LifeSciences Corp.	II	Apr-20-2018
11	LINK BIO CORP	II	Jul-25-2024
12	Materialise USA LLC	II	Aug-24-2022
13	Waldemar Link GmbH & Co. KG (Corp. Hq.)	II	Aug-26-2013
14	Zimmer Inc.	II	Dec-14-2010
15	Zimmer Inc.	II	Jan-23-2009
16	Zimmer, Inc.	II	Dec-06-2013
17	Zimmer, Inc.	II	Nov-19-2012
18	Zimmer, Inc.	II	Sep-28-2012