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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 34 38

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 138 138
Packaging Problem 54 54
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
Tear, Rip or Hole in Device Packaging 5 5
Insufficient Information 5 5
Material Fragmentation 4 4
Difficult to Open or Remove Packaging Material 3 3
Defective Device 3 3
Disassembly 3 3
Loss of or Failure to Bond 2 2
Crack 2 2
Patient Device Interaction Problem 2 2
Migration 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Pressure Problem 1 1
Output Problem 1 1
Material Twisted/Bent 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unclear Information 1 1
Device Dislodged or Dislocated 1 1
Device Operates Differently Than Expected 1 1
Device Packaging Compromised 1 1
Migration or Expulsion of Device 1 1
Connection Problem 1 1
Unintended Power Up 1 1
Component Falling 1 1
Contamination 1 1
Flaked 1 1
Failure to Fire 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 156 182
No Clinical Signs, Symptoms or Conditions 97 144
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
Pain 2 2
Extravasation 2 2
Hearing Loss 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Death 1 1
Joint Disorder 1 1
Osteolysis 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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