TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1609	1610
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
Fracture	5	5
Material Split, Cut or Torn	5	5
Appropriate Term/Code Not Available	2	2
Patient Device Interaction Problem	2	2
Nonstandard Device	2	2
Failure to Osseointegrate	2	2
Fitting Problem	1	1
Dull, Blunt	1	1
Loss of Osseointegration	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
Use of Device Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Display or Visual Feedback Problem	1	1
Device Handling Problem	1	1
Sharp Edges	1	1
Separation Problem	1	1
Unintended Compatibility	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	1093	1094
Insufficient Information	455	455
No Clinical Signs, Symptoms or Conditions	327	327
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
Inflammation	1	1
Sinus Perforation	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