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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
2014 44 44
2015 49 49
2016 16 16
2017 20 20
2018 22 22
2019 33 39
2020 167 200
2021 58 71
2022 46 50
2023 65 330
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 139 139
Packaging Problem 74 74
Detachment of Device or Device Component 61 335
Metal Shedding Debris 37 37
Delivered as Unsterile Product 36 46
Break 25 25
Disassembly 21 21
Material Disintegration 18 55
Biocompatibility 17 17
Unsealed Device Packaging 14 14
Leak/Splash 8 8
Insufficient Information 8 8
Device Operates Differently Than Expected 7 7
Material Fragmentation 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Device 4 4
Fracture 4 4
Loss of or Failure to Bond 4 4
Device Contamination with Chemical or Other Material 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Crack 3 3
Device Inoperable 3 3
Component Missing 2 2
Device Or Device Fragments Location Unknown 2 2
Material Discolored 2 2
Flaked 2 2
Pressure Problem 2 2
Mechanical Jam 2 2
Appropriate Term/Code Not Available 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
Device Dislodged or Dislocated 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Improper Flow or Infusion 1 1
Incorrect Device Or Component Shipped 1 1
Output Problem 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Contamination 1 1
Failure to Fire 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Delivery System Failure 1 1
Activation, Positioning or Separation Problem 1 1
Failure to Deliver 1 1
Use of Device Problem 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Failure to Pump 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 196 222
No Clinical Signs, Symptoms or Conditions 182 494
No Known Impact Or Consequence To Patient 66 81
No Consequences Or Impact To Patient 61 80
No Information 11 11
Insufficient Information 6 255
Therapeutic Effects, Unexpected 6 6
No Code Available 5 5
Unspecified Infection 4 4
Pain 4 4
Extravasation 2 2
Osteolysis 2 2
Not Applicable 1 1
Hearing Loss 1 1
Failure of Implant 1 1
Cardiac Arrest 1 1
Death 1 1
Joint Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III Jun-30-2009
2 Medtronic Spine LLC, formerly Kyphon Inc II Mar-11-2011
3 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
4 Stryker Instruments Div. of Stryker Corporation II Nov-14-2013
5 Stryker Instruments Div. of Stryker Corporation II Jan-25-2012
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