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TPLC
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Device
probe
Regulation Description
Orthopedic manual surgical instrument.
Product Code
HXB
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
39
39
2021
35
35
2022
41
41
2023
47
47
2024
36
36
2025
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
128
128
Fracture
40
40
Material Twisted/Bent
14
14
Material Deformation
12
12
Entrapment of Device
9
9
Material Fragmentation
5
5
Device-Device Incompatibility
5
5
Material Separation
3
3
Material Integrity Problem
3
3
Material Split, Cut or Torn
3
3
Contamination /Decontamination Problem
3
3
Use of Device Problem
2
2
No Apparent Adverse Event
2
2
Illegible Information
2
2
Detachment of Device or Device Component
2
2
Device Slipped
1
1
Component Missing
1
1
Material Discolored
1
1
Mechanical Jam
1
1
Difficult to Insert
1
1
Incorrect Measurement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
149
149
Foreign Body In Patient
19
19
No Consequences Or Impact To Patient
9
9
No Known Impact Or Consequence To Patient
9
9
Insufficient Information
9
9
Device Embedded In Tissue or Plaque
6
6
No Patient Involvement
4
4
Injury
2
2
Perforation
1
1
Spinal Column Injury
1
1
No Code Available
1
1
Failure of Implant
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Sklar Instruments
II
Jan-16-2025
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