TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1531	1532
Entrapment of Device	50	50
Difficult to Remove	31	31
Material Separation	28	28
Material Fragmentation	9	9
Detachment of Device or Device Component	6	6
Material Split, Cut or Torn	5	5
Fracture	5	5
Patient Device Interaction Problem	2	2
Failure to Osseointegrate	2	2
Appropriate Term/Code Not Available	2	2
Nonstandard Device	2	2
Fitting Problem	1	1
Separation Problem	1	1
Unintended Movement	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Sharp Edges	1	1
Unintended Compatibility	1	1
Lack of Effect	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Display or Visual Feedback Problem	1	1
Dull, Blunt	1	1
Loss of Osseointegration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	1069	1070
Insufficient Information	434	434
No Clinical Signs, Symptoms or Conditions	290	290
Foreign Body In Patient	136	136
Pain	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Needle Stick/Puncture	5	5
Laceration(s)	5	5
Tooth Fracture	4	4
Failure of Implant	3	3
Abrasion	3	3
Unspecified Tissue Injury	3	3
Hemorrhage/Bleeding	3	3
Unspecified Infection	2	2
Swelling/ Edema	2	2
Sinus Perforation	1	1
Inflammation	1	1
Discomfort	1	1
Deformity/ Disfigurement	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	US Endodontics, LLC	II	Feb-06-2025