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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
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
Product CodeJEB
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 3 3
2018 3 3
2019 1 1
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Unintended Movement 2 2
Loose or Intermittent Connection 1 1
Self-Activation or Keying 1 1
Device Inoperable 1 1
Malposition of Device 1 1
Positioning Problem 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Information 2 2
Pain 1 1
Injury 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Fall 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems II Feb-20-2018
2 Schaerer Medical USA Inc II Nov-08-2016
3 Zimmer Biomet, Inc. II Feb-28-2018
4 Zimmer Surgical Inc II May-28-2019
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