TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1284	1285
Material Fragmentation	8	8
Material Separation	6	6
Material Split, Cut or Torn	5	5
Detachment of Device or Device Component	5	5
Patient Device Interaction Problem	2	2
Failure to Osseointegrate	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Fracture	2	2
Nonstandard Device	2	2
Activation, Positioning or Separation Problem	1	1
Entrapment of Device	1	1
Unintended Movement	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	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
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	1138	1139
Insufficient Information	496	496
No Clinical Signs, Symptoms or Conditions	350	350
Foreign Body In Patient	136	136
Tooth Loss	47	47
Pain	20	20
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Needle Stick/Puncture	5	5
Laceration(s)	5	5
Tooth Fracture	4	4
Failure of Implant	3	3
Abrasion	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Unspecified Tissue Injury	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