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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
Product CodeJDZ
Regulation Number 888.4210
Device Class 1

MDR Year MDR Reports MDR Events
2018 22 22
2019 33 39
2020 167 200
2021 58 71
2022 46 50
2023 18 67

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 133 133
Packaging Problem 63 63
Detachment of Device or Device Component 35 94
Delivered as Unsterile Product 29 38
Material Disintegration 18 55
Unsealed Device Packaging 11 11
Biocompatibility 8 8
Break 7 7
Tear, Rip or Hole in Device Packaging 5 5
Insufficient Information 5 5
Defective Device 4 4
Material Fragmentation 4 4
Disassembly 3 3
Crack 3 3
Metal Shedding Debris 3 3
Difficult to Open or Remove Packaging Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unclear Information 1 1
Pressure Problem 1 1
Output Problem 1 1
Material Twisted/Bent 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Device Packaging Compromised 1 1
Unintended Power Up 1 1
Contamination 1 1
Flaked 1 1
Fracture 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Pump 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 151 177
No Clinical Signs, Symptoms or Conditions 127 223
No Consequences Or Impact To Patient 35 54
No Known Impact Or Consequence To Patient 30 45
No Information 6 6
Insufficient Information 4 43
Extravasation 2 2
Failure of Implant 1 1
Death 1 1
Not Applicable 1 1
Unspecified Infection 1 1
Joint Disorder 1 1
Hearing Loss 1 1

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