TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BENNETT JACOBY, DDS, MS, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	2
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	177	177
Failure to Cut	62	62
Device-Device Incompatibility	50	50
Entrapment of Device	43	43
Material Twisted/Bent	10	10
Fracture	8	8
Overheating of Device	6	6
Defective Device	4	4
Naturally Worn	4	4
Material Deformation	4	4
Separation Failure	4	4
No Apparent Adverse Event	3	3
Dull, Blunt	3	3
Mechanical Problem	2	2
Component or Accessory Incompatibility	2	2
Detachment of Device or Device Component	2	3
Use of Device Problem	2	2
Failure to Osseointegrate	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Osseointegration Problem	1	1
Positioning Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Excessive Heating	1	1
Material Integrity Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Fragmentation	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	168	169
No Consequences Or Impact To Patient	56	56
Foreign Body In Patient	46	46
Insufficient Information	26	26
Failure of Implant	19	19
No Code Available	12	12
Burn(s)	6	6
No Known Impact Or Consequence To Patient	4	4
No Patient Involvement	4	4
Unspecified Tissue Injury	3	3
Not Applicable	3	3
Injury	3	3
Necrosis	2	2
No Information	2	2
Osteopenia/ Osteoporosis	1	1
Device Embedded In Tissue or Plaque	1	1
Nerve Damage	1	1
Pain	1	1
Unspecified Infection	1	1
Impaired Healing	1	1
Numbness	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nobel Biocare Usa Llc	II	Feb-19-2020