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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
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 2
MECTRON S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 50 50
2020 55 55
2021 84 84
2022 63 64
2023 63 63
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Break 191 191
Failure to Cut 67 67
Device-Device Incompatibility 52 52
Entrapment of Device 44 44
Material Twisted/Bent 10 10
Fracture 8 8
Material Deformation 7 7
Overheating of Device 6 6
Separation Failure 4 4
Defective Device 4 4
Naturally Worn 4 4
No Apparent Adverse Event 3 3
Dull, Blunt 3 3
Component or Accessory Incompatibility 2 2
Mechanical Problem 2 2
Material Fragmentation 2 2
Use of Device Problem 2 2
Failure to Osseointegrate 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 3
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Positioning Problem 1 1
Contamination /Decontamination Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Improper or Incorrect Procedure or Method 1 1
Osseointegration Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 180
No Consequences Or Impact To Patient 56 56
Foreign Body In Patient 47 47
Insufficient Information 35 35
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
Not Applicable 3 3
Injury 3 3
Unspecified Tissue Injury 3 3
Necrosis 2 2
No Information 2 2
Unspecified Infection 1 1
Impaired Healing 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Osteopenia/ Osteoporosis 1 1
Nerve Damage 1 1
Numbness 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

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