TPLC - Total Product Life Cycle

• Device: drill, bone, powered
• Product Code: DZI
• Regulation Number: 872.4120
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BENNETT JACOBY, DDS, MS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BONART CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DMETEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DONG IL TECHNOLOGY LTD.
	SUBSTANTIALLY EQUIVALENT	2
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	2
MECTRON S.P.A
	SUBSTANTIALLY EQUIVALENT	1
MECTRON S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
MECTRON SPA
	SUBSTANTIALLY EQUIVALENT	2
PIEZOSURGERY S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SATELEC
	SUBSTANTIALLY EQUIVALENT	2
1.  K091252  IMPLANT CENTER 2
2.  K091331  PIEZOTOME 2
SATELEC - ACTEON GROUP
	SUBSTANTIALLY EQUIVALENT	1
SATELEC - ACTEON, INC.
	SUBSTANTIALLY EQUIVALENT	1
SILFRADENT S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA)
	SUBSTANTIALLY EQUIVALENT	1
W & H DENTALWERK BUERMOOS GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	50	50
2015	39	39
2016	43	43
2017	38	38
2018	73	73
2019	50	50
2020	55	55
2021	84	84
2022	63	64
2023	63	63
2024	26	26

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	336	336
Failure to Cut	63	63
Device-Device Incompatibility	57	57
Entrapment of Device	45	45
Overheating of Device	20	20
Material Twisted/Bent	17	17
Material Fragmentation	15	15
Device Operates Differently Than Expected	14	14
Device Markings/Labelling Problem	12	12
Fracture	8	8
Detachment Of Device Component	5	5
Device Stops Intermittently	5	5
Detachment of Device or Device Component	5	6
Material Deformation	5	5
Naturally Worn	4	4
Separation Failure	4	4
Dull, Blunt	4	4
Defective Device	4	4
Use of Device Problem	4	4
Difficult to Insert	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Temperature Problem	3	3
No Apparent Adverse Event	3	3
Packaging Problem	2	2
Mechanical Problem	2	2
Device Inoperable	2	2
Failure To Adhere Or Bond	2	2
Failure to Osseointegrate	2	2
Component or Accessory Incompatibility	2	2
Connection Problem	1	1
Failure to Align	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Component Missing	1	1
Device Or Device Fragments Location Unknown	1	1
Ambient Noise Problem	1	1
Contamination /Decontamination Problem	1	1
Bent	1	1
Thermal Decomposition of Device	1	1
Component Falling	1	1
Component Incompatible	1	1
Peeled/Delaminated	1	1
Difficult To Position	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Sticking	1	1
Positioning Problem	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Excessive Heating	1	1
Missing Information	1	1
Osseointegration Problem	1	1
Mechanical Jam	1	1
Mechanics Altered	1	1
Material Distortion	1	1
Material Integrity Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	169	170
No Known Impact Or Consequence To Patient	134	134
No Consequences Or Impact To Patient	86	86
Foreign Body In Patient	56	56
No Patient Involvement	33	33
No Code Available	31	31
Insufficient Information	26	26
Failure of Implant	20	20
Device Embedded In Tissue or Plaque	19	19
No Information	9	9
Burn(s)	8	8
Sedation	8	8
Injury	3	3
Necrosis	3	3
Not Applicable	3	3
Unspecified Tissue Injury	3	3
Impaired Healing	2	2
Pain	2	2
Osteopenia/ Osteoporosis	1	1
Numbness	1	1
Burn, Thermal	1	1
Nerve Damage	1	1
Vessel Or Plaque, Device Embedded In	1	1
Unspecified Infection	1	1
Laceration(s)	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
2	Nobel Biocare Usa Llc	II	Aug-09-2016
3	Stryker Instruments Div. of Stryker Corporation	II	Nov-16-2009