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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 42
2023 47 47
2024 36 38
2025 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Break 147 150
Fracture 41 41
Material Twisted/Bent 14 14
Material Deformation 14 16
Entrapment of Device 11 12
Device-Device Incompatibility 5 5
Material Fragmentation 5 5
Material Separation 4 4
Material Split, Cut or Torn 3 3
Material Integrity Problem 3 3
Contamination /Decontamination Problem 3 3
Use of Device Problem 2 2
Detachment of Device or Device Component 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
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 169
Foreign Body In Patient 21 21
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 9 9
No Consequences Or Impact To Patient 9 9
Device Embedded In Tissue or Plaque 6 7
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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