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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device driver, wire, and bone drill, manual
Regulation Description Bone cutting instrument and accessories.
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
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
OSTEOMED LLC
  SUBSTANTIALLY EQUIVALENT 1
PROTOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH CMF
  SUBSTANTIALLY EQUIVALENT 1
VHA DEAN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 17 27
2021 21 24
2022 23 24
2023 22 25
2024 13 14
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 24 24
Adverse Event Without Identified Device or Use Problem 12 12
Device Remains Activated 9 16
Unintended Power Up 8 17
Patient-Device Incompatibility 5 5
Malposition of Device 5 5
Physical Resistance/Sticking 5 7
Manufacturing, Packaging or Shipping Problem 5 5
Device-Device Incompatibility 5 5
Entrapment of Device 4 4
Inadequacy of Device Shape and/or Size 4 4
Patient Device Interaction Problem 3 3
Inaccurate Information 3 3
Labelling, Instructions for Use or Training Problem 2 2
Device Markings/Labelling Problem 2 2
Compatibility Problem 1 1
Device Difficult to Setup or Prepare 1 1
Fracture 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Cut 1 1
Positioning Failure 1 1
Inadequate Instructions for Healthcare Professional 1 1
Product Quality Problem 1 1
Insufficient Information 1 1
Defective Device 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 87
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Consequences Or Impact To Patient 5 14
No Patient Involvement 4 13
Insufficient Information 4 4
Foreign Body In Patient 3 3
Joint Dislocation 3 3
No Code Available 2 2
Failure of Implant 2 2
Loss of Range of Motion 1 1
Nerve Damage 1 1
Malunion of Bone 1 1
Tooth Fracture 1 1

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