• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device drill, bone, powered
Regulation Description Bone cutting instrument and accessories.
Product CodeDZI
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
  SUBSTANTIALLY EQUIVALENT 1
MECTRON SPA
  SUBSTANTIALLY EQUIVALENT 1
SAESHIN PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SATELEC-ACTEON GROUP
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 43 43
2017 38 38
2018 73 73
2019 50 50
2020 55 55
2021 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 174 174
Device-Device Incompatibility 34 34
Entrapment of Device 20 20
Material Twisted/Bent 16 16
Device Markings/Labelling Problem 12 12
Material Fragmentation 10 10
Overheating of Device 9 9
Failure to Cut 9 9
Device Operates Differently Than Expected 6 6
Naturally Worn 4 4
Use of Device Problem 4 4
Dull, Blunt 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Detachment Of Device Component 2 2
Packaging Problem 2 2
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Failure to Osseointegrate 1 1
Separation Failure 1 1
Difficult To Position 1 1
Device Slipped 1 1
Mechanical Problem 1 1
Component Incompatible 1 1
Component Falling 1 1
Connection Problem 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Fitting Problem 1 1
Osseointegration Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Missing Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Mechanics Altered 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 80 80
No Known Impact Or Consequence To Patient 72 72
Foreign Body In Patient 33 33
No Code Available 29 29
No Patient Involvement 28 28
No Clinical Signs, Symptoms or Conditions 21 21
Device Embedded In Tissue or Plaque 11 11
Failure of Implant 7 7
No Information 5 5
Burn(s) 4 4
Sedation 3 3
Not Applicable 3 3
Injury 3 3
Necrosis 3 3
Impaired Healing 2 2
Nerve Damage 1 1
Pain 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Numbness 1 1
Vessel Or Plaque, Device Embedded In 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Nobel Biocare Usa Llc II Aug-09-2016
-
-