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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
337
337
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
898
898
Adverse Event Without Identified Device or Use Problem
335
335
Device Slipped
247
247
Failure to Align
220
220
Migration
197
197
Material Deformation
171
171
Loosening of Implant Not Related to Bone-Ingrowth
162
162
Migration or Expulsion of Device
130
130
Fracture
110
110
Device Dislodged or Dislocated
98
98
Loose or Intermittent Connection
58
58
Mechanical Problem
38
38
Detachment of Device or Device Component
34
34
Mechanics Altered
29
29
Device-Device Incompatibility
28
28
No Apparent Adverse Event
24
24
Malposition of Device
22
22
Material Integrity Problem
21
21
Mechanical Jam
21
21
Material Twisted/Bent
17
17
Appropriate Term/Code Not Available
17
17
Device Damaged by Another Device
15
15
Use of Device Problem
14
14
Material Fragmentation
10
10
Detachment Of Device Component
10
10
Material Erosion
9
9
Biocompatibility
8
8
Crack
8
8
Insufficient Information
8
8
Packaging Problem
8
8
Expulsion
8
8
Unintended Movement
7
7
Torn Material
7
7
Naturally Worn
7
7
Metal Shedding Debris
6
6
Entrapment of Device
6
6
Scratched Material
6
6
Patient-Device Incompatibility
6
6
Material Disintegration
5
5
Defective Component
5
5
Material Split, Cut or Torn
5
5
Improper or Incorrect Procedure or Method
4
4
Bent
4
4
Material Separation
4
4
Patient Device Interaction Problem
4
4
Device Operational Issue
3
3
Material Protrusion/Extrusion
3
3
Failure to Advance
3
3
Peeled/Delaminated
3
3
Osseointegration Problem
3
3
Difficult to Insert
3
3
Connection Problem
3
3
Device Markings/Labelling Problem
3
3
Difficult to Advance
2
2
Flaked
2
2
Ejection Problem
2
2
Inadequate Instructions for Healthcare Professional
2
2
Component Missing
2
2
Degraded
2
2
Difficult to Open or Close
2
2
Nonstandard Device
2
2
Defective Device
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Inoperable
2
2
Corroded
2
2
Compatibility Problem
2
2
Positioning Failure
2
2
Inaccurate Information
2
2
Device Handling Problem
1
1
Inadequate or Insufficient Training
1
1
Device Issue
1
1
Separation Failure
1
1
Device Operates Differently Than Expected
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Contamination with Chemical or Other Material
1
1
Tear, Rip or Hole in Device Packaging
1
1
Leak/Splash
1
1
Misconnection
1
1
Unstable
1
1
Product Quality Problem
1
1
Device Fell
1
1
Activation, Positioning or Separation Problem
1
1
Difficult To Position
1
1
Unintended Ejection
1
1
Collapse
1
1
Therapeutic or Diagnostic Output Failure
1
1
Noise, Audible
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Component Misassembled
1
1
Unintended System Motion
1
1
Device Damaged Prior to Use
1
1
Positioning Problem
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
627
627
Pain
395
395
Failure of Implant
155
155
No Code Available
137
137
No Consequences Or Impact To Patient
107
107
Seroma
66
66
Unspecified Infection
65
65
Device Embedded In Tissue or Plaque
65
65
Injury
60
60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
60
60
Bone Fracture(s)
50
50
No Patient Involvement
44
44
Insufficient Information
36
36
Foreign Body In Patient
33
33
No Information
32
32
Spinal Column Injury
32
32
Post Operative Wound Infection
30
30
Stenosis
30
30
Discomfort
29
29
Paralysis
22
22
Patient Problem/Medical Problem
20
20
Neurological Deficit/Dysfunction
20
20
Non-union Bone Fracture
19
19
Numbness
18
18
Neck Pain
18
18
Ambulation Difficulties
15
15
Not Applicable
15
15
Spinal Cord Injury
15
15
Weakness
14
14
Nerve Damage
14
14
Reaction
13
13
Fall
13
13
Unspecified Nervous System Problem
11
11
Disability
10
10
Neuropathy
10
10
Cerebrospinal Fluid Leakage
9
9
Burning Sensation
9
9
Hematoma
9
9
Swelling
7
7
Unspecified Tissue Injury
7
7
Hemorrhage/Bleeding
7
7
Purulent Discharge
7
7
Ossification
6
6
Arthritis
6
6
Hypersensitivity/Allergic reaction
6
6
Low Blood Pressure/ Hypotension
6
6
Inflammation
6
6
Osteolysis
5
5
Foreign Body Reaction
5
5
Necrosis
5
5
Rupture
5
5
Pressure Sores
5
5
Fever
4
4
Muscle Weakness
4
4
Headache
4
4
Dizziness
4
4
Blood Loss
4
4
Inadequate Osseointegration
4
4
Death
4
4
Joint Laxity
4
4
Movement Disorder
3
3
Inadequate Pain Relief
3
3
Nausea
3
3
Tingling
3
3
Brain Injury
3
3
Loss of Range of Motion
3
3
Respiratory Failure
3
3
Muscle Spasm(s)
3
3
Cyst(s)
3
3
Thrombosis
3
3
Undesired Nerve Stimulation
3
3
Complaint, Ill-Defined
3
3
Anxiety
3
3
Skin Discoloration
3
3
Rash
2
2
Staphylococcus Aureus
2
2
Sepsis
2
2
Fatigue
2
2
Wound Dehiscence
2
2
Abscess
2
2
Ulcer
2
2
Thrombus
2
2
Perforation of Vessels
2
2
Osteopenia/ Osteoporosis
2
2
Decreased Sensitivity
2
2
Sleep Dysfunction
2
2
Deformity/ Disfigurement
2
2
Perforation of Esophagus
2
2
Spinal Arachnoiditis
2
2
Shaking/Tremors
2
2
Depression
2
2
Impaired Healing
2
2
Cardiac Arrest
2
2
Unspecified Musculoskeletal problem
2
2
Pulmonary Embolism
2
2
Embolism/Embolus
2
2
Intervertebral Disc Compression or Protrusion
2
2
Stroke/CVA
2
2
Infarction, Cerebral
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
May-08-2020
6
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
II
Oct-11-2018
7
Zimmer Biomet Spine Inc.
II
Feb-22-2019
8
Zimmer Biomet, Inc.
II
Jun-05-2019
9
ulrich medical USA Inc
II
Mar-02-2020
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