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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drill, bone, powered
Product CodeDZI
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
BENNETT JACOBY, DDS, MS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
MECTRON S.P.A
  SUBSTANTIALLY EQUIVALENT 1
  1.  K171326  Piezosurgery White
MECTRON SPA
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC - ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 73 73
2019 50 50
2020 55 55
2021 84 84
2022 66 67
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 172 172
Device-Device Incompatibility 47 47
Failure to Cut 38 38
Entrapment of Device 38 38
Material Twisted/Bent 17 17
Device Markings/Labelling Problem 11 11
Overheating of Device 10 10
Fracture 5 5
Use of Device Problem 4 4
Material Deformation 4 4
Naturally Worn 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Dull, Blunt 3 3
Separation Failure 3 3
Failure to Osseointegrate 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Detachment of Device or Device Component 2 3
Device Operates Differently Than Expected 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Osseointegration Problem 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Excessive Heating 1 1
Missing Information 1 1
Difficult To Position 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Component Falling 1 1
Component Incompatible 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 121
No Consequences Or Impact To Patient 78 78
Foreign Body In Patient 49 49
No Known Impact Or Consequence To Patient 29 29
No Patient Involvement 15 15
Failure of Implant 15 15
No Code Available 14 14
Burn(s) 6 6
No Information 4 4
Insufficient Information 4 4
Not Applicable 3 3
Necrosis 3 3
Injury 3 3
Impaired Healing 2 2
Unspecified Tissue Injury 2 2
Osteopenia/ Osteoporosis 1 1
Device Embedded In Tissue or Plaque 1 1
Numbness 1 1
Nerve Damage 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
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