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TPLC
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show TPLC since
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Device
prosthesis, chin, internal
Product Code
FWP
Regulation Number
878.3550
Device Class
2
Premarket Reviews
Manufacturer
Decision
IMPLANTECH ASSOCIATES INC.
SUBSTANTIALLY EQUIVALENT
2
KEOSAN TRADING CO.
SUBSTANTIALLY EQUIVALENT
1
STRYKER LEIBINGER GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
15
15
2020
6
6
2021
13
13
2022
12
12
2023
6
6
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
23
23
Insufficient Information
5
5
Device Dislodged or Dislocated
4
4
Appropriate Term/Code Not Available
3
3
Inadequacy of Device Shape and/or Size
3
3
Malposition of Device
2
2
Device Appears to Trigger Rejection
2
2
Output Problem
2
2
Expulsion
2
2
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
No Apparent Adverse Event
1
1
Patient Device Interaction Problem
1
1
Difficult to Remove
1
1
Material Erosion
1
1
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Patient-Device Incompatibility
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
16
16
Pain
7
7
Bacterial Infection
6
6
Insufficient Information
4
4
Impaired Healing
4
4
No Clinical Signs, Symptoms or Conditions
3
3
No Code Available
3
3
Swelling/ Edema
3
3
Fluid Discharge
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Information
2
2
Device Embedded In Tissue or Plaque
2
2
Meningitis
2
2
Inflammation
2
2
Failure of Implant
2
2
Post Operative Wound Infection
2
2
Cerebral Edema
2
2
Pocket Erosion
2
2
Inadequate Osseointegration
1
1
No Known Impact Or Consequence To Patient
1
1
Deformity/ Disfigurement
1
1
Airway Obstruction
1
1
Swelling
1
1
Loss of Range of Motion
1
1
Foreign Body In Patient
1
1
Skin Infection
1
1
Discomfort
1
1
Purulent Discharge
1
1
Wound Dehiscence
1
1
Physical Asymmetry
1
1
Hemorrhage/Bleeding
1
1
Ecchymosis
1
1
Edema
1
1
Skin Erosion
1
1
Hematoma
1
1
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