TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	5515	5515
Naturally Worn	1596	1596
Device-Device Incompatibility	1318	1318
Scratched Material	1054	1054
Crack	916	916
Detachment of Device or Device Component	681	681
Material Deformation	484	484
Fracture	468	468
Material Twisted/Bent	412	412
Contamination /Decontamination Problem	312	312
Illegible Information	302	302
Material Integrity Problem	209	209
Mechanical Jam	160	160
No Apparent Adverse Event	149	149
Peeled/Delaminated	148	148
Material Discolored	145	145
Component Missing	126	126
Appropriate Term/Code Not Available	118	118
Adverse Event Without Identified Device or Use Problem	92	92
Insufficient Information	72	72
Corroded	68	68
Unintended Movement	68	68
Entrapment of Device	67	67
Incorrect Measurement	55	55
Use of Device Problem	54	54
Physical Resistance/Sticking	40	40
Failure to Cut	40	40
Loose or Intermittent Connection	29	29
Mechanical Problem	24	24
Structural Problem	22	22
Device Contamination With Biological Material	22	22
Device Dislodged or Dislocated	22	22
Dull, Blunt	21	21
Disassembly	19	19
Difficult to Remove	19	19
Material Fragmentation	18	18
Connection Problem	18	18
Compatibility Problem	15	15
Bent	14	14
Improper or Incorrect Procedure or Method	13	13
Device Operates Differently Than Expected	13	13
Off-Label Use	10	10
Loss of Osseointegration	10	10
Difficult to Insert	10	10
Difficult to Open or Close	9	9
Fitting Problem	8	8
Separation Failure	7	7
Inadequacy of Device Shape and/or Size	7	7
Loss of or Failure to Bond	7	7
Separation Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7957	7957
No Consequences Or Impact To Patient	1871	1871
Insufficient Information	741	741
No Information	428	428
No Known Impact Or Consequence To Patient	289	289
No Code Available	150	150
No Patient Involvement	135	135
Not Applicable	86	86
Foreign Body In Patient	42	42
Pain	38	38
Reaction	31	31
Bone Fracture(s)	24	24
Unspecified Infection	23	23
Device Embedded In Tissue or Plaque	10	10
Injury	9	9
Limb Fracture	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Joint Dislocation	6	6
Loss of Range of Motion	5	5
Physical Asymmetry	4	4
Osteolysis	4	4
Joint Laxity	4	4
Metal Related Pathology	3	3
Cyst(s)	3	3
Unspecified Tissue Injury	3	3
Failure of Implant	2	2
Bruise/Contusion	2	2
Inflammation	2	2
Discomfort	2	2
Swelling/ Edema	2	2
Laceration(s)	2	2
Ambulation Difficulties	1	1
Pulmonary Embolism	1	1
Infiltration into Tissue	1	1
Tissue Damage	1	1
Non-union Bone Fracture	1	1
Fall	1	1
Depression	1	1
Joint Swelling	1	1
Nerve Damage	1	1
Paralysis	1	1
Foreign Body Reaction	1	1
Blood Loss	1	1
Synovitis	1	1
Adhesion(s)	1	1
Unspecified Musculoskeletal problem	1	1
Inadequate Osseointegration	1	1
Death	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Feb-12-2018
2	Biomet Microfixation, LLC	II	May-12-2017
3	DePuy Orthopaedics, Inc.	II	Jul-20-2022
4	Integra LifeSciences Corp.	II	Apr-20-2018
5	LINK BIO CORP	II	Jul-25-2024
6	Materialise USA LLC	II	Aug-24-2022