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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dispenser, cement
Product CodeKIH
Regulation Number 888.4200
Device Class 1

MDR Year MDR Reports MDR Events
2017 14 14
2018 15 15
2019 29 29
2020 23 23
2021 30 30
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 39 39
Mechanical Jam 15 15
Adverse Event Without Identified Device or Use Problem 12 12
Failure to Eject 10 10
Appropriate Term/Code Not Available 9 9
Chemical Problem 8 8
Defective Device 5 5
Mechanics Altered 4 4
Loss of or Failure to Bond 4 4
Defective Component 4 4
Fracture 3 3
Partial Blockage 2 2
Device Handling Problem 2 2
Device-Device Incompatibility 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Extrusion 1 1
Inaccurate Dispensing 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Explosion 1 1
Packaging Problem 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Expiration Date Error 1 1
Detachment Of Device Component 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Migration or Expulsion of Device 1 1
Failure to Prime 1 1
Difficult to Remove 1 1
Material Separation 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 41 41
No Clinical Signs, Symptoms or Conditions 26 26
No Known Impact Or Consequence To Patient 10 10
No Code Available 9 9
Foreign Body In Patient 8 8
Extravasation 4 4
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
Pain 3 3
No Patient Involvement 2 2
Numbness 2 2
Bone Fracture(s) 2 2
Necrosis 2 2
Abrasion 2 2
No Information 2 2
Adhesion(s) 1 1
Death 1 1
Edema 1 1
Neuropathy 1 1
Inflammation 1 1
Spinal Cord Injury 1 1
Sudden Cardiac Death 1 1
Synovitis 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Apr-01-2019
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