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TPLC
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show TPLC since
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2023
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Device
driver, wire, and bone drill, manual
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
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
22
25
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
Adverse Event Without Identified Device or Use Problem
5
5
Physical Resistance/Sticking
5
7
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
58
75
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
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