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TPLC
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show TPLC since
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2020
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2024
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Device
drill, bone, powered
Product Code
DZI
Regulation Number
872.4120
Device Class
2
Premarket Reviews
Manufacturer
Decision
BENNETT JACOBY, DDS, MS, INC.
SUBSTANTIALLY EQUIVALENT
1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
SUBSTANTIALLY EQUIVALENT
2
SAESHIN PRECISION CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
50
50
2020
55
55
2021
84
84
2022
63
64
2023
63
63
2024
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
177
177
Failure to Cut
62
62
Device-Device Incompatibility
50
50
Entrapment of Device
43
43
Material Twisted/Bent
10
10
Fracture
8
8
Overheating of Device
6
6
Defective Device
4
4
Naturally Worn
4
4
Material Deformation
4
4
Separation Failure
4
4
No Apparent Adverse Event
3
3
Dull, Blunt
3
3
Mechanical Problem
2
2
Component or Accessory Incompatibility
2
2
Detachment of Device or Device Component
2
3
Use of Device Problem
2
2
Failure to Osseointegrate
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Osseointegration Problem
1
1
Positioning Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Excessive Heating
1
1
Material Integrity Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Fragmentation
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
168
169
No Consequences Or Impact To Patient
56
56
Foreign Body In Patient
46
46
Insufficient Information
26
26
Failure of Implant
19
19
No Code Available
12
12
Burn(s)
6
6
No Known Impact Or Consequence To Patient
4
4
No Patient Involvement
4
4
Unspecified Tissue Injury
3
3
Not Applicable
3
3
Injury
3
3
Necrosis
2
2
No Information
2
2
Osteopenia/ Osteoporosis
1
1
Device Embedded In Tissue or Plaque
1
1
Nerve Damage
1
1
Pain
1
1
Unspecified Infection
1
1
Impaired Healing
1
1
Numbness
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Nobel Biocare Usa Llc
II
Feb-19-2020
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