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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 2
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 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 183 183
Failure to Cut 64 64
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 173 174
No Consequences Or Impact To Patient 56 56
Foreign Body In Patient 46 46
Insufficient Information 30 30
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
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