Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
appliance, fixation, spinal interlaminal
Product Code
KWP
Regulation Number
888.3050
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
518
518
2020
796
796
2021
529
529
2022
336
336
2023
331
331
2024
149
149
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
829
829
Adverse Event Without Identified Device or Use Problem
327
327
Device Slipped
259
259
Migration
191
191
Loosening of Implant Not Related to Bone-Ingrowth
176
176
Material Deformation
133
133
Device Dislodged or Dislocated
124
124
Fracture
111
111
Failure to Align
80
80
Migration or Expulsion of Device
74
74
Device Appears to Trigger Rejection
46
46
Loose or Intermittent Connection
39
39
Mechanical Problem
38
38
Material Twisted/Bent
38
38
Device-Device Incompatibility
37
37
Detachment of Device or Device Component
35
35
Mechanics Altered
30
30
No Apparent Adverse Event
29
29
Mechanical Jam
27
27
Malposition of Device
23
23
Material Integrity Problem
22
22
Device Damaged by Another Device
15
15
Use of Device Problem
15
15
Patient-Device Incompatibility
11
11
Appropriate Term/Code Not Available
11
11
Insufficient Information
9
9
Packaging Problem
9
9
Entrapment of Device
9
9
Crack
9
9
Expulsion
8
8
Compatibility Problem
7
7
Naturally Worn
7
7
Scratched Material
7
7
Patient Device Interaction Problem
6
6
Material Fragmentation
6
6
Product Quality Problem
6
6
Material Separation
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Difficult to Advance
4
4
Unintended Movement
4
4
Osseointegration Problem
4
4
Biocompatibility
3
3
Material Disintegration
3
3
Failure to Advance
3
3
Difficult to Insert
3
3
Degraded
3
3
Material Erosion
3
3
Corroded
2
2
Positioning Failure
2
2
Inadequate Instructions for Healthcare Professional
2
2
Defective Device
2
2
Improper or Incorrect Procedure or Method
2
2
Nonstandard Device
2
2
Peeled/Delaminated
2
2
Inadequacy of Device Shape and/or Size
2
2
Connection Problem
2
2
Activation, Positioning or Separation Problem
2
2
Difficult to Open or Close
2
2
Therapeutic or Diagnostic Output Failure
2
2
Ejection Problem
2
2
Device Fell
1
1
Component Misassembled
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Positioning Problem
1
1
Device Markings/Labelling Problem
1
1
Material Protrusion/Extrusion
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Too Rigid or Stiff
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Inadequate or Insufficient Training
1
1
Unstable
1
1
Leak/Splash
1
1
Misconnection
1
1
Material Discolored
1
1
Unintended Ejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
851
851
No Known Impact Or Consequence To Patient
583
583
Pain
405
405
Failure of Implant
162
162
No Code Available
99
99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
72
72
Unspecified Infection
66
66
Seroma
66
66
Device Embedded In Tissue or Plaque
63
63
Insufficient Information
62
62
Implant Pain
50
50
Bone Fracture(s)
49
49
Injury
41
41
No Patient Involvement
38
38
Non-union Bone Fracture
30
30
Foreign Body In Patient
29
29
Post Operative Wound Infection
28
28
Stenosis
28
28
No Consequences Or Impact To Patient
25
25
Discomfort
24
24
Ambulation Difficulties
23
23
Patient Problem/Medical Problem
19
19
Numbness
18
18
Nerve Damage
18
18
Paralysis
18
18
Neurological Deficit/Dysfunction
17
17
Spinal Column Injury
17
17
Neck Pain
16
16
No Information
14
14
Spinal Cord Injury
13
13
Neuropathy
13
13
Fall
13
13
Osteolysis
12
12
Unspecified Nervous System Problem
11
11
Hematoma
11
11
Hemorrhage/Bleeding
10
10
Joint Laxity
10
10
Disability
9
9
Weakness
9
9
Burning Sensation
8
8
Purulent Discharge
7
7
Reaction
7
7
Unspecified Tissue Injury
7
7
Swelling/ Edema
6
6
Swelling
6
6
Inadequate Osseointegration
6
6
Cerebrospinal Fluid Leakage
6
6
Ossification
6
6
Arthritis
6
6
Low Blood Pressure/ Hypotension
6
6
Inflammation
6
6
Necrosis
5
5
Foreign Body Reaction
5
5
Impaired Healing
5
5
Rupture
4
4
Unspecified Musculoskeletal problem
4
4
Fever
4
4
Headache
4
4
Hypersensitivity/Allergic reaction
4
4
Loss of Range of Motion
4
4
Muscle Spasm(s)
3
3
Muscle Weakness
3
3
Nausea
3
3
Sepsis
3
3
Skin Discoloration
3
3
Thrombosis
3
3
Cyst(s)
3
3
Death
3
3
Movement Disorder
3
3
Blood Loss
3
3
Complaint, Ill-Defined
3
3
Pressure Sores
3
3
Anxiety
3
3
Dizziness
3
3
Paraplegia
3
3
Respiratory Failure
3
3
Shaking/Tremors
2
2
Inadequate Pain Relief
2
2
Perforation of Esophagus
2
2
Electric Shock
2
2
Osteopenia/ Osteoporosis
2
2
Spinal Arachnoiditis
2
2
Decreased Sensitivity
2
2
Constipation
2
2
Embolism/Embolus
2
2
Intervertebral Disc Compression or Protrusion
2
2
Cardiac Arrest
2
2
Pulmonary Embolism
2
2
Abscess
2
2
Wound Dehiscence
2
2
Fatigue
2
2
Stroke/CVA
2
2
Infarction, Cerebral
2
2
Thrombus
2
2
Tingling
2
2
Rash
2
2
Paresis
2
2
Pleural Effusion
1
1
Pneumonia
1
1
Pneumothorax
1
1
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
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
-
-