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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
114
132
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
739
803
Break
523
523
Material Fragmentation
182
182
Mechanical Jam
142
142
Complete Loss of Power
102
102
Tear, Rip or Hole in Device Packaging
52
52
Delivered as Unsterile Product
43
51
Dull, Blunt
31
31
Failure to Cut
27
27
Device Contaminated During Manufacture or Shipping
21
21
Excessive Heating
21
21
Packaging Problem
20
20
Detachment of Device or Device Component
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
6
6
Material Disintegration
6
6
Continuous Firing
5
5
Mechanical Problem
5
5
Fitting Problem
5
5
Device Contamination with Chemical or Other Material
5
5
Device-Device Incompatibility
5
5
Output Problem
5
5
Temperature Problem
4
4
Expiration Date Error
4
4
Vibration
4
4
Melted
4
4
Peeled/Delaminated
3
3
Failure to Power Up
3
3
Material Discolored
3
3
Use of Device Problem
3
3
Flaked
3
3
Device Slipped
3
3
Component Missing
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Patient Device Interaction Problem
3
3
Power Problem
3
3
Premature Separation
3
3
Physical Resistance/Sticking
3
3
Material Split, Cut or Torn
2
2
Component Misassembled
2
2
Noise, Audible
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
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
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
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
Material Too Soft/Flexible
1
1
Therapeutic or Diagnostic Output Failure
1
1
Scratched Material
1
1
Naturally Worn
1
1
Device Fell
1
1
Activation Problem
1
1
Misassembled During Installation
1
1
Device Contaminated at the User Facility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1281
1353
No Consequences Or Impact To Patient
247
247
Insufficient Information
167
169
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
Pain
5
5
Not Applicable
5
5
Superficial (First Degree) Burn
5
5
Unspecified Infection
4
4
Unspecified Tissue Injury
4
4
Burn, Thermal
3
3
Tissue Damage
3
3
Hemorrhage/Bleeding
3
3
Bone Fracture(s)
2
2
Patient Problem/Medical Problem
2
2
Injury
2
2
Limited Mobility Of The Implanted Joint
1
1
Tissue Breakdown
1
1
Muscle/Tendon Damage
1
1
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
Myocardial Infarction
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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