TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Device-Device Incompatibility	1363	1363
Break	644	644
Unintended Movement	294	294
Failure to Cut	238	238
Naturally Worn	224	224
Material Deformation	221	221
Scratched Material	215	215
Appropriate Term/Code Not Available	166	166
Loose or Intermittent Connection	133	133
Difficult to Advance	115	115
Material Twisted/Bent	102	102
Adverse Event Without Identified Device or Use Problem	88	88
Connection Problem	83	83
Fracture	81	81
Structural Problem	67	67
Dull, Blunt	51	51
Device Damaged Prior to Use	44	44
Physical Resistance/Sticking	38	38
Mechanical Jam	37	37
Component Missing	35	35
Material Integrity Problem	35	35
Inadequacy of Device Shape and/or Size	34	34
Contamination /Decontamination Problem	33	33
Device Slipped	30	30
Chemical Problem	28	28
No Apparent Adverse Event	26	26
Illegible Information	24	24
Crack	22	22
Fitting Problem	21	21
Bent	20	20
Entrapment of Device	18	18
Difficult to Open or Close	17	17
Insufficient Information	16	16
Mechanical Problem	14	14
Difficult to Remove	13	13
Detachment of Device or Device Component	11	11
Device Dislodged or Dislocated	9	9
Tear, Rip or Hole in Device Packaging	7	7
Defective Device	6	6
Device Markings/Labelling Problem	6	6
Positioning Problem	6	6
Device Contaminated During Manufacture or Shipping	6	6
Device Operates Differently Than Expected	5	5
Difficult to Insert	5	5
Corroded	4	4
Device Contamination with Chemical or Other Material	4	4
Device Issue	4	4
Misconnection	4	4
Incomplete or Inadequate Connection	4	4
Off-Label Use	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1687	1687
No Consequences Or Impact To Patient	1204	1204
Insufficient Information	258	258
No Code Available	173	173
No Information	147	147
No Known Impact Or Consequence To Patient	134	134
Not Applicable	77	77
Bone Fracture(s)	39	39
Limb Fracture	23	23
Unspecified Tissue Injury	14	14
Pain	11	11
Joint Dislocation	9	9
Unspecified Infection	8	8
No Patient Involvement	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Joint Laxity	5	5
Foreign Body In Patient	3	3
Hip Fracture	2	2
Loss of Range of Motion	2	2
Damage to Ligament(s)	1	1
Fatigue	1	1
Inadequate Osseointegration	1	1
Foreign Body Reaction	1	1
Thrombosis/Thrombus	1	1
Nerve Damage	1	1
Discomfort	1	1
Fall	1	1
Scar Tissue	1	1
Physical Asymmetry	1	1
Deformity/ Disfigurement	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Greatbatch Medical	II	May-09-2017