Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 driver, wire, and bone drill, manual
Product CodeDZJ
Regulation Number 872.4120
Device Class 2


Premarket Reviews
ManufacturerDecision
3D LIFEPRINTS UK LTD.
  SUBSTANTIALLY EQUIVALENT 1
3D SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
CENTERMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL WINGS GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMMERSIVETOUCH
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 1
PROPEL ORTHODONTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
PROTOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH CMF
  SUBSTANTIALLY EQUIVALENT 1
VHA DEAN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 8 8
2019 4 5
2020 17 27
2021 21 24
2022 23 24
2023 21 24

Device Problems MDRs with this Device Problem Events in those MDRs
Break 27 27
Device Remains Activated 10 16
Unintended Power Up 8 18
Patient-Device Incompatibility 7 7
Entrapment of Device 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Physical Resistance/Sticking 5 7
Adverse Event Without Identified Device or Use Problem 4 4
Device-Device Incompatibility 4 4
Inadequacy of Device Shape and/or Size 4 4
Inaccurate Information 3 3
Malposition of Device 3 3
Patient Device Interaction Problem 3 3
Insufficient Information 2 2
Device Markings/Labelling Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Fracture 1 1
Positioning Failure 1 1
Compatibility Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Cut 1 1
Defective Device 1 1
No Apparent Adverse Event 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 74
No Consequences Or Impact To Patient 9 19
No Patient Involvement 7 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 5 5
Foreign Body In Patient 4 4
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 1 1
Malunion of Bone 1 1
Joint Dislocation 1 1
Tooth Fracture 1 1
Hematoma 1 1
Nerve Damage 1 1
Pulmonary Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medical Modeling, Inc. II Aug-09-2022
-
-