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TPLC
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Device
appliance, fixation, spinal interlaminal
Product Code
KWP
Regulation Number
888.3050
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
657
657
2019
518
518
2020
796
796
2021
529
529
2022
336
336
2023
235
235
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
982
982
Adverse Event Without Identified Device or Use Problem
342
342
Device Slipped
292
292
Failure to Align
220
220
Migration
209
209
Material Deformation
174
174
Loosening of Implant Not Related to Bone-Ingrowth
167
167
Migration or Expulsion of Device
130
130
Device Dislodged or Dislocated
120
120
Fracture
117
117
Loose or Intermittent Connection
58
58
Mechanical Problem
40
40
Detachment of Device or Device Component
40
40
Device-Device Incompatibility
39
39
Material Twisted/Bent
30
30
Mechanics Altered
29
29
Malposition of Device
27
27
No Apparent Adverse Event
27
27
Mechanical Jam
23
23
Material Integrity Problem
21
21
Appropriate Term/Code Not Available
19
19
Use of Device Problem
16
16
Device Damaged by Another Device
15
15
Packaging Problem
11
11
Material Fragmentation
10
10
Detachment Of Device Component
10
10
Crack
9
9
Entrapment of Device
9
9
Material Erosion
9
9
Expulsion
8
8
Biocompatibility
8
8
Insufficient Information
8
8
Torn Material
7
7
Unintended Movement
7
7
Compatibility Problem
7
7
Naturally Worn
7
7
Patient-Device Incompatibility
6
6
Metal Shedding Debris
6
6
Scratched Material
6
6
Material Split, Cut or Torn
5
5
Defective Component
5
5
Material Disintegration
5
5
Material Separation
5
5
Bent
4
4
Improper or Incorrect Procedure or Method
4
4
Osseointegration Problem
4
4
Patient Device Interaction Problem
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Connection Problem
3
3
Failure to Advance
3
3
Material Protrusion/Extrusion
3
3
Difficult to Advance
3
3
Device Operational Issue
3
3
Device Markings/Labelling Problem
3
3
Difficult to Insert
3
3
Degraded
3
3
Peeled/Delaminated
3
3
Nonstandard Device
2
2
Inadequacy of Device Shape and/or Size
2
2
Product Quality Problem
2
2
Device Inoperable
2
2
Positioning Failure
2
2
Corroded
2
2
Inadequate Instructions for Healthcare Professional
2
2
Difficult to Open or Close
2
2
Flaked
2
2
Defective Device
2
2
Activation, Positioning or Separation Problem
2
2
Component Missing
2
2
Therapeutic or Diagnostic Output Failure
2
2
Ejection Problem
2
2
Inaccurate Information
2
2
Device Fell
1
1
Positioning Problem
1
1
Component Misassembled
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Device Issue
1
1
Tear, Rip or Hole in Device Packaging
1
1
Device Damaged Prior to Use
1
1
Separation Failure
1
1
Device Contamination with Chemical or Other Material
1
1
Device Operates Differently Than Expected
1
1
Device Contaminated During Manufacture or Shipping
1
1
Leak/Splash
1
1
Unintended Ejection
1
1
Collapse
1
1
Material Discolored
1
1
Unstable
1
1
Inadequate or Insufficient Training
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Unintended System Motion
1
1
Difficult To Position
1
1
Misconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
938
938
No Clinical Signs, Symptoms or Conditions
752
752
Pain
435
435
Failure of Implant
180
180
No Code Available
137
137
No Consequences Or Impact To Patient
107
107
Device Embedded In Tissue or Plaque
70
70
Unspecified Infection
70
70
Seroma
67
67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
66
66
Injury
60
60
Bone Fracture(s)
55
55
No Patient Involvement
44
44
Insufficient Information
44
44
Foreign Body In Patient
34
34
Discomfort
33
33
Spinal Column Injury
33
33
No Information
32
32
Post Operative Wound Infection
31
31
Stenosis
30
30
Non-union Bone Fracture
27
27
Paralysis
23
23
Neck Pain
21
21
Patient Problem/Medical Problem
20
20
Neurological Deficit/Dysfunction
20
20
Numbness
19
19
Nerve Damage
18
18
Spinal Cord Injury
16
16
Ambulation Difficulties
15
15
Not Applicable
15
15
Weakness
14
14
Reaction
13
13
Fall
13
13
Hemorrhage/Bleeding
11
11
Unspecified Nervous System Problem
11
11
Hematoma
10
10
Neuropathy
10
10
Disability
10
10
Burning Sensation
9
9
Cerebrospinal Fluid Leakage
9
9
Inadequate Osseointegration
8
8
Purulent Discharge
7
7
Swelling
7
7
Unspecified Tissue Injury
7
7
Inflammation
6
6
Ossification
6
6
Arthritis
6
6
Hypersensitivity/Allergic reaction
6
6
Low Blood Pressure/ Hypotension
6
6
Foreign Body Reaction
6
6
Osteolysis
6
6
Pressure Sores
5
5
Rupture
5
5
Necrosis
5
5
Muscle Weakness
4
4
Loss of Range of Motion
4
4
Fever
4
4
Death
4
4
Headache
4
4
Dizziness
4
4
Inadequate Pain Relief
4
4
Blood Loss
4
4
Swelling/ Edema
4
4
Joint Laxity
4
4
Movement Disorder
3
3
Paraplegia
3
3
Respiratory Failure
3
3
Anxiety
3
3
Complaint, Ill-Defined
3
3
Brain Injury
3
3
Tingling
3
3
Cyst(s)
3
3
Sepsis
3
3
Skin Discoloration
3
3
Thrombosis
3
3
Nausea
3
3
Muscle Spasm(s)
3
3
Undesired Nerve Stimulation
3
3
Thrombus
2
2
Rash
2
2
Staphylococcus Aureus
2
2
Stroke/CVA
2
2
Infarction, Cerebral
2
2
Cardiac Arrest
2
2
Pulmonary Embolism
2
2
Abscess
2
2
Fatigue
2
2
Wound Dehiscence
2
2
Perforation of Vessels
2
2
Ulcer
2
2
Deformity/ Disfigurement
2
2
Depression
2
2
Perforation of Esophagus
2
2
Impaired Healing
2
2
Osteopenia/ Osteoporosis
2
2
Shaking/Tremors
2
2
Sleep Dysfunction
2
2
Constipation
2
2
Electric Shock
2
2
Decreased Sensitivity
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
K2M, Inc
II
Mar-01-2022
2
K2M, Inc.
II
Jun-30-2022
3
Medicrea International
II
Mar-11-2020
4
Medicrea International
II
Jan-24-2020
5
Medtronic Sofamor Danek USA Inc
II
Apr-19-2023
6
Medtronic Sofamor Danek USA Inc
II
May-08-2020
7
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
II
Oct-11-2018
8
Zimmer Biomet Spine Inc.
II
Feb-22-2019
9
Zimmer Biomet, Inc.
II
Jun-05-2019
10
ulrich medical USA Inc
II
Mar-02-2020
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