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TPLC
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Device
methyl methacrylate for cranioplasty
Product Code
GXP
Regulation Number
882.5300
Device Class
2
Premarket Reviews
Manufacturer
Decision
DIMENSIONAL BIOCERAMICS, LLC
SUBSTANTIALLY EQUIVALENT
1
ORTHOCON, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
9
9
2020
31
31
2021
14
14
2022
3
3
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
41
41
Migration
4
4
Break
3
3
Fracture
3
3
Device Appears to Trigger Rejection
2
2
Defective Component
1
1
Loss of Osseointegration
1
1
Chemical Problem
1
1
Improper Chemical Reaction
1
1
Migration or Expulsion of Device
1
1
Crack
1
1
Material Disintegration
1
1
Loss of or Failure to Bond
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
18
18
Unspecified Infection
15
15
Pain
14
14
Inflammation
9
9
Post Operative Wound Infection
9
9
Cerebrospinal Fluid Leakage
6
6
No Clinical Signs, Symptoms or Conditions
5
5
No Known Impact Or Consequence To Patient
4
4
Headache
4
4
Neurological Deficit/Dysfunction
3
3
No Consequences Or Impact To Patient
3
3
Impaired Healing
3
3
Inadequate Osseointegration
2
2
Hearing Impairment
2
2
Swelling
2
2
Visual Impairment
2
2
Wound Dehiscence
2
2
Insufficient Information
1
1
Vomiting
1
1
Device Embedded In Tissue or Plaque
1
1
Post Traumatic Wound Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Swelling/ Edema
1
1
Nausea
1
1
Foreign Body In Patient
1
1
Facial Nerve Paralysis
1
1
Pocket Erosion
1
1
Weakness
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Skeletal Kinetics, Llc
II
Jan-15-2021
2
Skeletal Kinetics, Llc
II
Jul-15-2020
3
Skeletal Kinetics, Llc
II
May-20-2020
4
Stryker Leibinger GmbH & Co. KG
II
Apr-19-2021
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