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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mixer, cement, for clinical use
Regulation Description Cement mixer for clinical use.
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2015 49 49
2016 16 16
2017 20 20
2018 22 22
2019 33 33
2020 158 158

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 133 133
Metal Shedding Debris 30 30
Delivered as Unsterile Product 18 18
Biocompatibility 17 17
Detachment of Device or Device Component 13 13
Packaging Problem 13 13
Break 12 12
Disassembly 8 8
Material Disintegration 6 6
Material Fragmentation 5 5
Leak/Splash 5 5
Loss of or Failure to Bond 4 4
Tear, Rip or Hole in Device Packaging 4 4
Insufficient Information 4 4
Device Contamination with Chemical or Other Material 3 3
Device Operates Differently Than Expected 3 3
Device Or Device Fragments Location Unknown 2 2
Device Inoperable 2 2
Flaked 2 2
Migration 2 2
Device Fell 1 1
Unclear Information 1 1
Appropriate Term/Code Not Available 1 1
Pressure Problem 1 1
Knife 1 1
Use of Device Problem 1 1
Failure to Pump 1 1
Inadequacy of Device Shape and/or Size 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Connector 1 1
Electrical /Electronic Property Problem 1 1
Component Falling 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1
Failure to Fire 1 1
Connection Problem 1 1
Delivery System Failure 1 1
Defective Device 1 1
Component Missing 1 1
Failure to Deliver 1 1
Device Packaging Compromised 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 183 183
No Consequences Or Impact To Patient 55 55
No Known Impact Or Consequence To Patient 47 47
No Information 5 5
No Code Available 4 4
Pain 4 4
Unspecified Infection 2 2
Therapeutic Effects, Unexpected 2 2
Osteolysis 2 2
Extravasation 2 2
Hearing Loss 1 1
Death 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
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