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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
Regulation Description Bone cutting instrument and accessories.
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
NAKANISHI, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 55 55
2021 84 85
2022 63 67
2023 63 63
2024 58 60
2025 40 40
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 206 209
Failure to Cut 73 73
Device-Device Incompatibility 54 55
Entrapment of Device 47 47
Overheating of Device 13 13
Fracture 8 9
Material Deformation 7 7
Noise, Audible 5 5
Excessive Heating 5 5
Defective Device 4 4
Contamination /Decontamination Problem 4 4
Material Twisted/Bent 3 3
Complete Loss of Power 3 3
No Apparent Adverse Event 3 3
Separation Failure 3 3
Appropriate Term/Code Not Available 2 3
Component or Accessory Incompatibility 2 2
Detachment of Device or Device Component 2 3
Material Fragmentation 2 2
Mechanical Problem 1 2
Inadequacy of Device Shape and/or Size 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Material Integrity Problem 1 2
Insufficient Information 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 229 233
Foreign Body In Patient 48 48
Insufficient Information 41 42
No Consequences Or Impact To Patient 27 27
Failure of Implant 16 17
No Code Available 10 10
Burn(s) 7 7
Injury 3 3
Unspecified Tissue Injury 3 3
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 2
Osteopenia/ Osteoporosis 1 1
No Known Impact Or Consequence To Patient 1 1
Laceration(s) 1 1
Pain 1 1
Hemorrhage/Bleeding 1 1

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