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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, surgical with orthopedic accessories, manual
Product CodeJEB
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 3 3
2019 1 1
2020 1 1
2021 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Device-Device Incompatibility 2 2
Unintended Movement 2 2
Noise, Audible 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Self-Activation or Keying 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Information 2 2
Fall 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems II Feb-20-2018
2 Zimmer Biomet, Inc. II Feb-28-2018
3 Zimmer Surgical Inc II May-28-2019
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