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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
2016 16 16
2017 20 20
2018 22 22
2019 33 39
2020 167 200

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 135 135
Delivered as Unsterile Product 18 21
Biocompatibility 17 17
Detachment of Device or Device Component 14 21
Packaging Problem 13 13
Break 9 9
Material Disintegration 7 36
Metal Shedding Debris 7 7
Insufficient Information 6 6
Tear, Rip or Hole in Device Packaging 5 5
Material Fragmentation 4 4
Loss of or Failure to Bond 4 4
Disassembly 3 3
Device Contamination with Chemical or Other Material 3 3
Migration 2 2
Flaked 2 2
Leak/Splash 2 2
Component Falling 1 1
Unintended Power Up 1 1
Failure to Fire 1 1
Inadequacy of Device Shape and/or Size 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Connection Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Crack 1 1
Migration or Expulsion of Device 1 1
Failure to Pump 1 1
Use of Device Problem 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Output Problem 1 1
Patient Device Interaction Problem 1 1
Unclear Information 1 1
Defective Device 1 1
Delivery System Failure 1 1
Knife 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 160 186
No Consequences Or Impact To Patient 53 72
No Known Impact Or Consequence To Patient 32 47
No Information 8 8
No Clinical Signs, Symptoms or Conditions 5 17
Pain 3 3
No Code Available 2 2
Extravasation 2 2
Hearing Loss 1 1
Osteolysis 1 1
Not Applicable 1 1
Death 1 1
Unspecified Infection 1 1

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