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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device probe
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXB
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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 122 122
Fracture 40 40
Material Twisted/Bent 14 14
Material Deformation 12 12
Entrapment of Device 8 8
Device-Device Incompatibility 5 5
Material Fragmentation 5 5
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Use of Device Problem 2 2
Material Separation 2 2
No Apparent Adverse Event 2 2
Illegible Information 2 2
Device Slipped 1 1
Difficult to Insert 1 1
Material Discolored 1 1
Component Missing 1 1
Incorrect Measurement 1 1
Detachment of Device or Device Component 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 143 143
Foreign Body In Patient 18 18
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 9 9
No Consequences Or Impact To Patient 9 9
Device Embedded In Tissue or Plaque 6 6
No Patient Involvement 4 4
Injury 2 2
Failure of Implant 1 1
No Code Available 1 1
Perforation 1 1
Spinal Column Injury 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sklar Instruments II Jan-16-2025
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