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TPLC
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Device
blade, saw, general & plastic surgery, surgical
Product Code
GFA
Regulation Number
878.4820
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
331
331
2020
276
276
2021
394
394
2022
442
442
2023
383
437
2024
81
99
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
735
799
Break
514
514
Material Fragmentation
175
175
Mechanical Jam
140
140
Complete Loss of Power
100
100
Tear, Rip or Hole in Device Packaging
52
52
Delivered as Unsterile Product
43
51
Dull, Blunt
31
31
Failure to Cut
27
27
Excessive Heating
21
21
Packaging Problem
20
20
Detachment of Device or Device Component
20
20
Device Contaminated During Manufacture or Shipping
20
20
Contamination /Decontamination Problem
18
18
Appropriate Term/Code Not Available
16
16
Overheating of Device
15
15
Entrapment of Device
14
14
Material Integrity Problem
11
11
Material Separation
11
11
Separation Problem
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Defective Device
9
9
Contamination
8
8
Insufficient Cooling
7
7
Smoking
7
7
Material Twisted/Bent
7
7
Material Deformation
6
6
No Apparent Adverse Event
6
6
Insufficient Information
5
5
Output Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Device-Device Incompatibility
5
5
Continuous Firing
5
5
Material Disintegration
5
5
Mechanical Problem
5
5
Melted
4
4
Vibration
4
4
Expiration Date Error
4
4
Temperature Problem
4
4
Patient Device Interaction Problem
3
3
Power Problem
3
3
Premature Separation
3
3
Fitting Problem
3
3
Device Slipped
3
3
Component Missing
3
3
Use of Device Problem
3
3
Flaked
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Peeled/Delaminated
3
3
Failure to Power Up
3
3
Material Discolored
3
3
Disconnection
2
2
Thermal Decomposition of Device
2
2
Corroded
2
2
Crack
2
2
Degraded
2
2
Device Emits Odor
2
2
Material Erosion
2
2
Leak/Splash
2
2
Loose or Intermittent Connection
2
2
Device Damaged by Another Device
2
2
Connection Problem
2
2
Particulates
2
2
Inadequacy of Device Shape and/or Size
2
2
Improper or Incorrect Procedure or Method
2
2
Noise, Audible
2
2
Physical Resistance/Sticking
2
2
Component Misassembled
2
2
Material Too Soft/Flexible
1
1
Material Split, Cut or Torn
1
1
Therapeutic or Diagnostic Output Failure
1
1
Scratched Material
1
1
Naturally Worn
1
1
Device Fell
1
1
Misassembled During Installation
1
1
Device Contaminated at the User Facility
1
1
Activation Problem
1
1
Defective Component
1
1
Patient-Device Incompatibility
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Markings/Labelling Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Failure to Auto Stop
1
1
Failure to Shut Off
1
1
Device Unsafe to Use in Environment
1
1
Human-Device Interface Problem
1
1
Material Protrusion/Extrusion
1
1
Fire
1
1
Misconnection
1
1
Moisture Damage
1
1
Nonstandard Device
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Retraction Problem
1
1
Self-Activation or Keying
1
1
Burst Container or Vessel
1
1
Electrical /Electronic Property Problem
1
1
Material Frayed
1
1
Difficult to Insert
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1256
1328
No Consequences Or Impact To Patient
247
247
Insufficient Information
160
162
No Known Impact Or Consequence To Patient
144
144
No Patient Involvement
96
96
Foreign Body In Patient
76
76
Device Embedded In Tissue or Plaque
18
18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Burn(s)
8
8
No Code Available
7
7
No Information
6
6
Laceration(s)
6
6
Not Applicable
5
5
Superficial (First Degree) Burn
5
5
Unspecified Infection
4
4
Unspecified Tissue Injury
4
4
Pain
4
4
Tissue Damage
3
3
Hemorrhage/Bleeding
3
3
Burn, Thermal
3
3
Patient Problem/Medical Problem
2
2
Injury
2
2
Bone Fracture(s)
2
2
Abrasion
1
1
Purulent Discharge
1
1
Edema
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoxia
1
1
Failure of Implant
1
1
Perforation of Vessels
1
1
Hypovolemia
1
1
Discomfort
1
1
Skin Discoloration
1
1
Swelling
1
1
Limited Mobility Of The Implanted Joint
1
1
Tissue Breakdown
1
1
Muscle/Tendon Damage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
II
Jan-11-2023
2
Stryker Instruments Div. of Stryker Corporation
II
Apr-24-2019
3
Synvasive Technology Inc
II
Apr-06-2020
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