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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
2021 35 35
2022 41 42
2023 47 47
2024 36 38
2025 37 37
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 136 139
Fracture 35 35
Material Deformation 17 19
Entrapment of Device 12 13
Material Twisted/Bent 10 10
Device-Device Incompatibility 5 5
Material Separation 5 5
Material Fragmentation 4 4
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
No Apparent Adverse Event 2 2
Illegible Information 2 2
Material Discolored 1 1
Use of Device Problem 1 1
Incorrect Measurement 1 1
Detachment of Device or Device Component 1 1
Failure to Advance 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 173 175
Foreign Body In Patient 17 17
Insufficient Information 10 10
Device Embedded In Tissue or Plaque 6 7
Failure of Implant 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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