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TPLC
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Device
rongeur
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HTX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
29
29
2021
26
26
2022
23
23
2023
14
14
2024
24
24
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
50
50
Material Fragmentation
11
11
Fracture
9
9
Material Integrity Problem
8
8
Material Separation
7
7
Detachment of Device or Device Component
6
6
Contamination /Decontamination Problem
5
5
Peeled/Delaminated
4
4
Material Erosion
4
4
Material Twisted/Bent
3
3
Appropriate Term/Code Not Available
3
3
Compatibility Problem
3
3
Device Fell
3
3
Loose or Intermittent Connection
2
2
Material Deformation
2
2
Component Missing
2
2
Mechanical Problem
2
2
Solder Joint Fracture
1
1
Entrapment of Device
1
1
Difficult to Open or Close
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
80
80
Insufficient Information
16
16
Foreign Body In Patient
11
11
No Known Impact Or Consequence To Patient
7
7
No Consequences Or Impact To Patient
5
5
Device Embedded In Tissue or Plaque
3
3
Hemorrhage/Bleeding
2
2
Patient Problem/Medical Problem
2
2
Deformity/ Disfigurement
1
1
No Patient Involvement
1
1
Nerve Damage
1
1
Unspecified Tissue Injury
1
1
Spinal Cord Injury
1
1
Pain
1
1
No Code Available
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sklar Instruments
II
Jan-16-2025
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