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TPLC
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show TPLC since
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Device
instrument, manual, surgical, general use
Product Code
MDM
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
400
400
2019
281
281
2020
245
245
2021
228
228
2022
182
182
2023
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
859
859
Fracture
80
80
Detachment of Device or Device Component
77
77
Entrapment of Device
69
69
Difficult to Remove
61
61
Insufficient Information
49
49
Adverse Event Without Identified Device or Use Problem
46
46
Detachment Of Device Component
41
41
Appropriate Term/Code Not Available
34
34
Material Fragmentation
28
28
Device Operates Differently Than Expected
25
25
Crack
24
24
Component Missing
21
21
Device Damaged by Another Device
16
16
Material Separation
14
14
Material Twisted/Bent
14
14
Mechanical Jam
13
13
Device Fell
13
13
Mechanical Problem
13
13
Dull, Blunt
12
12
Physical Resistance/Sticking
12
12
Connection Problem
10
10
Loose or Intermittent Connection
10
10
Material Split, Cut or Torn
9
9
Failure to Disinfect
8
8
Defective Device
7
7
Device Or Device Fragments Location Unknown
7
7
Misfire
7
7
Defective Component
6
6
Device-Device Incompatibility
6
6
Naturally Worn
6
6
Material Deformation
6
6
Patient Device Interaction Problem
5
5
Activation, Positioning or Separation Problem
5
5
Failure to Fire
5
5
Bent
5
5
Device Slipped
5
5
Corroded
4
4
Flaked
4
4
Difficult to Insert
4
4
Failure to Cut
4
4
Device Dislodged or Dislocated
4
4
Output Problem
4
4
Material Integrity Problem
3
3
Migration
3
3
Separation Problem
3
3
Failure to Advance
3
3
Use of Device Problem
3
3
Sticking
3
3
Particulates
3
3
Peeled/Delaminated
2
2
Migration or Expulsion of Device
2
2
Misconnection
2
2
Delivered as Unsterile Product
2
2
Unexpected Therapeutic Results
2
2
Device Inoperable
2
2
Product Quality Problem
2
2
Unstable
2
2
Disconnection
2
2
Disassembly
2
2
Component Falling
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
2
2
Failure to Align
2
2
Difficult or Delayed Activation
2
2
Device Markings/Labelling Problem
2
2
Difficult to Advance
2
2
Difficult to Open or Close
2
2
Contamination /Decontamination Problem
2
2
Firing Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Noise, Audible
2
2
Device Contamination with Chemical or Other Material
2
2
Device Contaminated During Manufacture or Shipping
2
2
Packaging Problem
2
2
Physical Property Issue
2
2
Power Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Difficult or Delayed Separation
1
1
Missing Information
1
1
Incomplete or Inadequate Connection
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Application Program Problem
1
1
Biocompatibility
1
1
Deformation Due to Compressive Stress
1
1
Failure to Disconnect
1
1
Structural Problem
1
1
Residue After Decontamination
1
1
Insufficient Flow or Under Infusion
1
1
Fitting Problem
1
1
Inability to Auto-Fill
1
1
Material Discolored
1
1
No Display/Image
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
284
284
No Clinical Signs, Symptoms or Conditions
200
200
No Consequences Or Impact To Patient
198
198
Device Embedded In Tissue or Plaque
163
163
Foreign Body In Patient
160
160
Insufficient Information
106
106
No Information
80
80
Injury
75
75
No Patient Involvement
42
42
No Code Available
18
18
Failure of Implant
16
16
Unspecified Infection
13
13
Pain
13
13
Bone Fracture(s)
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Tissue Damage
6
6
Not Applicable
5
5
Post Operative Wound Infection
4
4
Spinal Column Injury
4
4
Laceration(s)
3
3
Discomfort
3
3
Metal Related Pathology
3
3
Unspecified Tissue Injury
3
3
Swelling/ Edema
3
3
Joint Laxity
2
2
Patient Problem/Medical Problem
2
2
Hemorrhage/Bleeding
2
2
Purulent Discharge
2
2
Edema
1
1
Endophthalmitis
1
1
Hematoma
1
1
Wound Dehiscence
1
1
Vessel Or Plaque, Device Embedded In
1
1
Abrasion
1
1
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Bruise/Contusion
1
1
Muscular Rigidity
1
1
Inflammation
1
1
Synovitis
1
1
Perforation
1
1
Loss of Range of Motion
1
1
Complaint, Ill-Defined
1
1
Brain Injury
1
1
Ulcer
1
1
Pressure Sores
1
1
Anxiety
1
1
Burn, Thermal
1
1
Limited Mobility Of The Implanted Joint
1
1
Hip Fracture
1
1
Hypoesthesia
1
1
Arthralgia
1
1
Joint Dislocation
1
1
Impaired Healing
1
1
Increased Appetite
1
1
Subluxation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Dec-08-2022
2
ENDO Pharmaceuticals Solutions, Inc.
II
Dec-30-2022
3
FlexDex Inc.
II
Jan-27-2022
4
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-06-2023
5
Medtronic Sofamor Danek USA Inc
II
Feb-09-2018
6
Smith & Nephew, Inc.
II
Jan-24-2018
7
Trilliant Surgical Ltd.
II
Jul-02-2018
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