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TPLC
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show TPLC since
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Device
mixer, cement, for clinical use
Product Code
JDZ
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
12
17
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
62
340
Delivered as Unsterile Product
39
50
Metal Shedding Debris
37
37
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
186
503
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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