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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
2017 20 20
2018 22 22
2019 33 39
2020 167 200
2021 58 71
2022 46 50

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 138 138
Packaging Problem 62 62
Detachment of Device or Device Component 26 43
Delivered as Unsterile Product 24 29
Material Disintegration 15 49
Biocompatibility 13 13
Unsealed Device Packaging 11 11
Break 8 8
Metal Shedding Debris 6 6
Insufficient Information 5 5
Tear, Rip or Hole in Device Packaging 5 5
Material Fragmentation 4 4
Defective Device 4 4
Crack 3 3
Disassembly 3 3
Difficult to Open or Remove Packaging Material 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Loss of or Failure to Bond 2 2
Mechanical Jam 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Device Contamination with Chemical or Other Material 2 2
Physical Resistance/Sticking 1 1
Device Fell 1 1
Pressure Problem 1 1
Failure to Fire 1 1
Contamination 1 1
Inadequacy of Device Shape and/or Size 1 1
Unclear Information 1 1
Migration or Expulsion of Device 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Activation, Positioning or Separation Problem 1 1
Material Split, Cut or Torn 1 1
Device Dislodged or Dislocated 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Pump 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Component Falling 1 1
Unintended Power Up 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 156 182
No Clinical Signs, Symptoms or Conditions 109 156
No Consequences Or Impact To Patient 45 64
No Known Impact Or Consequence To Patient 31 46
No Information 7 7
No Code Available 2 2
Insufficient Information 2 2
Extravasation 2 2
Pain 2 2
Unspecified Infection 1 1
Failure of Implant 1 1
Death 1 1
Joint Disorder 1 1
Not Applicable 1 1
Hearing Loss 1 1
Osteolysis 1 1

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