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TPLC
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show TPLC since
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2024
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Device
retractor
Product Code
GAD
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
62
62
2020
86
86
2021
81
81
2022
80
80
2023
80
80
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
143
143
Device-Device Incompatibility
45
45
Crack
38
38
Detachment of Device or Device Component
33
33
Material Integrity Problem
26
26
Compatibility Problem
25
25
Material Twisted/Bent
15
15
Mechanical Jam
13
13
Adverse Event Without Identified Device or Use Problem
12
12
Fracture
12
12
Material Deformation
10
10
Mechanical Problem
9
9
Difficult to Remove
9
9
Component Missing
7
7
Contamination /Decontamination Problem
5
5
Mechanics Altered
5
5
Patient Device Interaction Problem
4
4
Device Slipped
4
4
Material Fragmentation
4
4
Material Separation
3
3
Use of Device Problem
3
3
Device Dislodged or Dislocated
3
3
Difficult to Open or Close
2
2
Difficult to Insert
2
2
Entrapment of Device
2
2
Positioning Failure
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
2
2
Fitting Problem
2
2
Device Difficult to Maintain
2
2
Positioning Problem
2
2
Scratched Material
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
Excessive Heating
2
2
Separation Problem
1
1
Device Handling Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Naturally Worn
1
1
No Apparent Adverse Event
1
1
Sharp Edges
1
1
Device Fell
1
1
Material Discolored
1
1
Material Erosion
1
1
Shipping Damage or Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Retraction Problem
1
1
No Device Output
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Markings/Labelling Problem
1
1
Fail-Safe Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Advance
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
248
248
No Consequences Or Impact To Patient
60
60
No Patient Involvement
24
24
No Known Impact Or Consequence To Patient
19
19
Insufficient Information
17
17
Foreign Body In Patient
13
13
No Information
7
7
Device Embedded In Tissue or Plaque
7
7
No Code Available
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Bone Fracture(s)
5
5
Cancer
4
4
Liver Damage/Dysfunction
3
3
Pain
3
3
Burn, Thermal
2
2
Hemorrhage/Bleeding
2
2
Perforation of Vessels
2
2
Superficial (First Degree) Burn
1
1
Unspecified Heart Problem
1
1
Blister
1
1
Unspecified Tissue Injury
1
1
Unintended Radiation Exposure
1
1
Not Applicable
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Necrosis
1
1
Granuloma
1
1
Wound Dehiscence
1
1
Death
1
1
Exsanguination
1
1
Blood Loss
1
1
Tissue Damage
1
1
Injury
1
1
Joint Dislocation
1
1
Osteolysis
1
1
Numbness
1
1
Spinal Cord Injury
1
1
Post Operative Wound Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AAP Implantate Ag
II
Apr-06-2020
2
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
3
Medagent Inc
II
Feb-23-2024
4
Medtronic Navigation, Inc.
II
Jan-12-2023
5
Smith & Nephew, Inc.
II
Aug-17-2020
6
TELEFLEX LLC
II
Jul-05-2023
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