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TPLC
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show TPLC since
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Device
prosthesis, wrist, hemi-, ulnar
Product Code
KXE
Regulation Number
888.3810
Device Class
2
Premarket Reviews
Manufacturer
Decision
APTIS MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
APTIS MEDICAL, LLC.
SUBSTANTIALLY EQUIVALENT
1
ASCENSION ORTHOPEDIC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
3
3
2016
3
3
2017
5
5
2018
3
3
2019
7
7
2020
5
5
2021
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
13
13
Insufficient Information
3
3
Shelf Life Exceeded
3
3
Installation-Related Problem
2
2
Break
2
2
Migration or Expulsion of Device
2
2
Fracture
2
2
Improper or Incorrect Procedure or Method
1
1
Material Erosion
1
1
Tear, Rip or Hole in Device Packaging
1
1
Naturally Worn
1
1
Detachment Of Device Component
1
1
Packaging Problem
1
1
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
6
6
Pain
6
6
No Information
4
4
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
3
3
Joint Dislocation
2
2
Bone Fracture(s)
2
2
Injury
2
2
Swelling
2
2
Sleep Dysfunction
1
1
Unspecified Infection
1
1
Neuropathy
1
1
Failure of Implant
1
1
Inflammation
1
1
Post Operative Wound Infection
1
1
Rash
1
1
Discomfort
1
1
Nerve Damage
1
1
Fall
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ascension Orthopedics, Inc
II
Feb-17-2012
2
Stryker Howmedica Osteonics Corp.
II
Aug-20-2015
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