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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
2019
24
24
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
66
66
Material Fragmentation
13
13
Fracture
12
12
Detachment of Device or Device Component
8
8
Material Integrity Problem
8
8
Material Separation
7
7
Contamination /Decontamination Problem
5
5
Device Fell
4
4
Material Erosion
4
4
Peeled/Delaminated
4
4
Appropriate Term/Code Not Available
3
3
Material Twisted/Bent
3
3
Loose or Intermittent Connection
3
3
Compatibility Problem
3
3
Component Missing
2
2
Material Deformation
2
2
Mechanical Problem
2
2
Difficult to Remove
1
1
Entrapment of Device
1
1
Solder Joint Fracture
1
1
Difficult to Open or Close
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Structural 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
No Known Impact Or Consequence To Patient
16
16
Foreign Body In Patient
15
15
No Consequences Or Impact To Patient
14
14
Device Embedded In Tissue or Plaque
3
3
Patient Problem/Medical Problem
2
2
Hemorrhage/Bleeding
2
2
Ambulation Difficulties
1
1
Spinal Cord Injury
1
1
No Patient Involvement
1
1
No Code Available
1
1
Deformity/ Disfigurement
1
1
No Information
1
1
Nerve Damage
1
1
Unspecified Tissue Injury
1
1
Failure of Implant
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sklar Instruments
II
Jan-16-2025
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