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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

Device Problems MDRs with this Device Problem Events in those MDRs
Break 49 49
Mechanical Problem 9 9
Device-Device Incompatibility 8 8
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
Crack 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Device Inoperable 1 1
Component Missing 1 1
Failure to Align 1 1
Bent 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 38 38
No Known Impact Or Consequence To Patient 21 21
No Patient Involvement 17 17
No Consequences Or Impact To Patient 10 10
Post Operative Wound Infection 2 2
Blood Loss 1 1
Injury 1 1
Sedation 1 1
Pain 1 1
Swelling 1 1
Not Applicable 1 1
No Information 1 1
No Code Available 1 1

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