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TPLC
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Device
driver, wire, and bone drill, manual
Regulation Description
Bone cutting instrument and accessories.
Product Code
DZJ
Regulation Number
872.4120
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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