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TPLC
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2024
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Device
cement obturator
Product Code
LZN
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOWMEDICA OSTEONICS, DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
1. K220838
Artisan Bone Plug, Universal Cement Restrictor
MDR Year
MDR Reports
MDR Events
2014
30
30
2015
41
41
2016
6
6
2017
6
6
2018
8
8
2019
11
11
2020
11
11
2021
12
12
2022
6
6
2023
13
13
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
73
73
Insufficient Information
22
22
Patient Device Interaction Problem
13
13
Adverse Event Without Identified Device or Use Problem
9
9
Break
6
6
Fracture
5
5
Device Slipped
5
5
Loose or Intermittent Connection
4
4
Device Operates Differently Than Expected
4
4
Delivered as Unsterile Product
4
4
Leak/Splash
3
3
Entrapment of Device
3
3
Failure to Osseointegrate
2
2
Packaging Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Migration
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Difficult To Position
1
1
Difficult to Remove
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Loss of or Failure to Bond
1
1
Nonstandard Device
1
1
Device Expiration Issue
1
1
Material Fragmentation
1
1
Detachment Of Device Component
1
1
Crack
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Osteolysis
69
69
Tissue Damage
36
36
Therapeutic Response, Decreased
25
25
No Clinical Signs, Symptoms or Conditions
9
9
No Code Available
6
6
No Consequences Or Impact To Patient
6
6
Failure of Implant
5
5
Unspecified Infection
5
5
Device Embedded In Tissue or Plaque
4
4
Osteopenia/ Osteoporosis
3
3
Bone Fracture(s)
3
3
No Known Impact Or Consequence To Patient
3
3
Cardiac Arrest
2
2
Pain
2
2
Foreign Body In Patient
2
2
No Information
2
2
Injury
1
1
Hip Fracture
1
1
Local Reaction
1
1
Inflammation
1
1
Death
1
1
Bacterial Infection
1
1
Implant Pain
1
1
Swelling/ Edema
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Depuy Ireland UC
II
Jan-12-2023
2
Stryker Corporation
II
Sep-19-2023
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