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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, bending or contouring
Product CodeHXP
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 14 14
2016 8 8
2017 3 3
2018 4 4
2019 4 4
2020 10 10
2021 19 19
2022 11 11
2023 5 5
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 51 51
Device-Device Incompatibility 12 12
Mechanical Problem 10 10
Device Operates Differently Than Expected 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Connection Problem 3 3
Sticking 2 2
Corroded 2 2
Mechanical Jam 2 2
Compatibility Problem 1 1
Crack 1 1
Material Fragmentation 1 1
Component Missing 1 1
Failure to Align 1 1
Bent 1 1
Material Deformation 1 1
Fracture 1 1
Device Inoperable 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 17 17
No Consequences Or Impact To Patient 10 10
Insufficient Information 4 4
Post Operative Wound Infection 2 2
Not Applicable 1 1
No Code Available 1 1
No Information 1 1
Blood Loss 1 1
Injury 1 1
Swelling 1 1
Pain 1 1
Sedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes USA HQ, Inc. II Nov-26-2013
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