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TPLC
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Device
accessories, arthroscopic
Product Code
NBH
Regulation Number
888.1100
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
358
358
2020
340
340
2021
389
389
2022
334
334
2023
491
491
2024
185
185
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
900
900
Material Separation
152
152
Material Deformation
147
147
Material Twisted/Bent
123
123
Degraded
115
115
Detachment of Device or Device Component
107
107
Difficult to Open or Close
103
103
Mechanical Jam
85
85
Device Contaminated During Manufacture or Shipping
58
58
Device-Device Incompatibility
41
41
Dull, Blunt
38
38
Material Fragmentation
33
33
Fracture
29
29
Adverse Event Without Identified Device or Use Problem
28
28
Flaked
22
22
Device Contamination with Chemical or Other Material
21
21
Appropriate Term/Code Not Available
20
20
Failure to Cut
16
16
Component Missing
16
16
Corroded
16
16
Mechanical Problem
15
15
Crack
14
14
Defective Device
13
13
Insufficient Information
13
13
Physical Resistance/Sticking
12
12
Use of Device Problem
11
11
Device Markings/Labelling Problem
10
10
Fluid/Blood Leak
10
10
Leak/Splash
10
10
Material Split, Cut or Torn
10
10
Material Integrity Problem
8
8
Device Dislodged or Dislocated
8
8
Delivered as Unsterile Product
7
7
Difficult to Remove
7
7
Entrapment of Device
7
7
Sharp Edges
7
7
Packaging Problem
6
6
Failure to Advance
6
6
Contamination /Decontamination Problem
6
6
Material Discolored
5
5
Loose or Intermittent Connection
5
5
Firing Problem
5
5
Illegible Information
5
5
Scratched Material
4
4
Problem with Sterilization
4
4
Failure to Cycle
4
4
Connection Problem
4
4
Failure to Align
4
4
Device Damaged Prior to Use
3
3
Solder Joint Fracture
3
3
Device Damaged by Another Device
3
3
Difficult to Advance
3
3
Contamination
3
3
Unstable
3
3
Device Fell
3
3
Activation Problem
2
2
Separation Problem
2
2
Unintended Movement
2
2
Component Misassembled
2
2
Noise, Audible
2
2
Positioning Problem
2
2
Output Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Nonstandard Device
2
2
Overheating of Device
2
2
Misfire
2
2
Contamination of Device Ingredient or Reagent
2
2
Product Quality Problem
2
2
Obstruction of Flow
1
1
Malposition of Device
1
1
Deformation Due to Compressive Stress
1
1
Capturing Problem
1
1
Residue After Decontamination
1
1
Tear, Rip or Hole in Device Packaging
1
1
Defective Component
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Activation, Positioning or Separation Problem
1
1
Infusion or Flow Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Peeled/Delaminated
1
1
Loss of Power
1
1
Migration or Expulsion of Device
1
1
Misassembled
1
1
Retraction Problem
1
1
Material Rupture
1
1
Positioning Failure
1
1
Difficult to Fold, Unfold or Collapse
1
1
Material Frayed
1
1
Difficult to Insert
1
1
Device Reprocessing Problem
1
1
Complete Blockage
1
1
Disconnection
1
1
Material Disintegration
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Naturally Worn
1
1
Patient Device Interaction Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1302
1302
No Known Impact Or Consequence To Patient
226
226
No Consequences Or Impact To Patient
218
218
Foreign Body In Patient
120
120
Insufficient Information
95
95
No Information
47
47
Not Applicable
32
32
No Patient Involvement
32
32
Device Embedded In Tissue or Plaque
30
30
No Code Available
17
17
Pain
13
13
Injury
13
13
Tissue Damage
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Failure of Implant
5
5
Laceration(s)
5
5
Unspecified Tissue Injury
4
4
Swelling/ Edema
3
3
Rupture
3
3
Extravasation
3
3
Perforation
3
3
Scar Tissue
2
2
Hypersensitivity/Allergic reaction
2
2
Exposure to Body Fluids
1
1
Capsular Contracture
1
1
Nerve Damage
1
1
Neuropathy
1
1
Itching Sensation
1
1
Burning Sensation
1
1
Numbness
1
1
Post Operative Wound Infection
1
1
Needle Stick/Puncture
1
1
Inadequate Osseointegration
1
1
Patient Problem/Medical Problem
1
1
Paresthesia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BioPro, Inc.
II
Aug-12-2019
2
Smith & Nephew, Inc.
II
Oct-27-2020
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