TPLC - Total Product Life Cycle

show TPLC since

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1209	1209
Degraded	204	204
Material Deformation	184	184
Detachment of Device or Device Component	169	169
Mechanical Jam	133	133
Material Twisted/Bent	114	114
Difficult to Open or Close	93	93
Material Separation	87	87
Device Damaged by Another Device	74	74
Device-Device Incompatibility	69	69
Fracture	68	68
Device Contaminated During Manufacture or Shipping	67	67
Material Fragmentation	51	51
Use of Device Problem	49	49
Dull, Blunt	39	39
Adverse Event Without Identified Device or Use Problem	28	28
Physical Resistance/Sticking	26	26
Corroded	24	24
Flaked	23	23
Defective Device	21	21
Appropriate Term/Code Not Available	18	18
Component Missing	17	17
Insufficient Information	17	17
Mechanical Problem	15	15
Contamination /Decontamination Problem	13	13
Leak/Splash	13	13
Failure to Advance	12	12
Device Dislodged or Dislocated	11	11
Crack	11	11
Material Integrity Problem	11	11
Delivered as Unsterile Product	11	11
Sharp Edges	11	11
Device Markings/Labelling Problem	10	10
Failure to Cut	10	10
Material Split, Cut or Torn	10	10
Packaging Problem	8	8
Scratched Material	8	8
Loose or Intermittent Connection	8	8
Positioning Failure	8	8
Device Damaged Prior to Use	7	7
Firing Problem	6	6
Display or Visual Feedback Problem	6	6
Illegible Information	5	5
Connection Problem	5	5
Difficult to Remove	5	5
Entrapment of Device	5	5
Device Contamination with Chemical or Other Material	4	4
Failure to Cycle	4	4
Naturally Worn	4	4
Problem with Sterilization	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2154	2154
Insufficient Information	177	177
Foreign Body In Patient	143	143
No Known Impact Or Consequence To Patient	82	82
No Consequences Or Impact To Patient	79	79
No Information	44	44
No Patient Involvement	29	29
Device Embedded In Tissue or Plaque	21	21
Injury	12	12
No Code Available	11	11
Pain	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Failure of Implant	6	6
Perforation	6	6
Tissue Damage	6	6
Not Applicable	5	5
Laceration(s)	5	5
Extravasation	4	4
Unspecified Tissue Injury	4	4
Rupture	3	3
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	2	2
Nerve Damage	2	2
Scar Tissue	2	2
Unspecified Infection	1	1
Neuropathy	1	1
Joint Dislocation	1	1
Sepsis	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Itching Sensation	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Burning Sensation	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Capsular Contracture	1	1
Joint Laxity	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smith & Nephew, Inc.	II	Oct-27-2020