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TPLC
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Device
cement obturator
Regulation Description
Surgical mesh.
Product Code
LZN
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOWMEDICA OSTEONICS, DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
11
11
2021
12
12
2022
6
6
2023
13
13
2024
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient-Device Incompatibility
20
20
Patient Device Interaction Problem
13
13
Adverse Event Without Identified Device or Use Problem
7
7
Fracture
4
4
Delivered as Unsterile Product
4
4
Leak/Splash
3
3
Break
3
3
Entrapment of Device
2
2
Device Handling Problem
1
1
Shipping Damage or Problem
1
1
Osseointegration Problem
1
1
Crack
1
1
Migration
1
1
Degraded
1
1
Improper or Incorrect Procedure or Method
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Osteolysis
22
22
No Clinical Signs, Symptoms or Conditions
10
10
Failure of Implant
4
4
Implant Pain
3
3
Pain
3
3
Bone Fracture(s)
2
2
Insufficient Information
2
2
Swelling/ Edema
2
2
Device Embedded In Tissue or Plaque
2
2
Loss of Range of Motion
1
1
No Consequences Or Impact To Patient
1
1
No Code Available
1
1
Cardiac Arrest
1
1
Inflammation
1
1
Discomfort
1
1
Bacterial Infection
1
1
Unspecified Infection
1
1
Inadequate Osseointegration
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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