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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 21 21
Device Remains Activated 9 12
Unintended Power Up 7 17
Manufacturing, Packaging or Shipping Problem 5 5
Physical Resistance/Sticking 5 7
Adverse Event Without Identified Device or Use Problem 4 4
Entrapment of Device 4 4
Patient-Device Incompatibility 4 4
Device-Device Incompatibility 4 4
Inadequacy of Device Shape and/or Size 3 3
Inaccurate Information 3 3
Malposition of Device 2 2
Insufficient Information 2 2
Patient Device Interaction Problem 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
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 58
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 3 3
Insufficient Information 3 3
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
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