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TPLC
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Device
spinal vertebral body replacement device
Product Code
MQP
Regulation Number
888.3060
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALPHATEC SPINE, INC.
SUBSTANTIALLY EQUIVALENT
1
ARFTX MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
ASTURA MEDICAL
SUBSTANTIALLY EQUIVALENT
1
CARBOFIX ORTHOPEDICS LTD.
SUBSTANTIALLY EQUIVALENT
1
CHOICE SPINE
SUBSTANTIALLY EQUIVALENT
1
CMF MEDICON SURGICAL INC.
SUBSTANTIALLY EQUIVALENT
1
CORELINK, LLC
SUBSTANTIALLY EQUIVALENT
1
DEPUY SYNTHES SPINE
SUBSTANTIALLY EQUIVALENT
1
GLOBUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
ICOTEC AG
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC SOFAMOR DANEK USA, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC SOFAMOR DANEK, USA INC.
SUBSTANTIALLY EQUIVALENT
1
NUVASIVE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD
SUBSTANTIALLY EQUIVALENT
1
ULRICH GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
117
117
2020
157
157
2021
208
208
2022
137
138
2023
71
71
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
185
185
Migration
109
109
Break
73
73
Mechanics Altered
60
60
Material Deformation
36
37
Activation Failure
27
27
Mechanical Jam
22
22
Collapse
22
22
Migration or Expulsion of Device
21
21
No Apparent Adverse Event
21
21
Fracture
20
20
Device Dislodged or Dislocated
18
18
Patient Device Interaction Problem
17
17
Appropriate Term/Code Not Available
17
17
Insufficient Information
16
16
Material Integrity Problem
16
16
Mechanical Problem
15
15
Detachment of Device or Device Component
13
13
Compatibility Problem
12
12
Material Twisted/Bent
10
10
Malposition of Device
9
9
Connection Problem
8
8
Device Slipped
7
7
Unintended Movement
7
7
Activation Problem
7
7
Use of Device Problem
6
6
Device-Device Incompatibility
4
4
Material Separation
4
4
Output Problem
4
4
Scratched Material
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Material Fragmentation
3
3
Device Damaged by Another Device
3
3
Activation, Positioning or Separation Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Failure to Advance
2
2
Degraded
2
2
Positioning Failure
2
2
Premature Activation
2
2
Loose or Intermittent Connection
2
2
Difficult to Insert
2
2
Noise, Audible
2
2
Therapeutic or Diagnostic Output Failure
2
2
Naturally Worn
2
2
Overcorrection
1
1
Physical Resistance/Sticking
1
1
Leak/Splash
1
1
Difficult to Remove
1
1
Inadequacy of Device Shape and/or Size
1
1
Disconnection
1
1
Entrapment of Device
1
1
Inflation Problem
1
1
Crack
1
1
Failure to Cut
1
1
Patient-Device Incompatibility
1
1
Biocompatibility
1
1
Structural Problem
1
1
Loss of Threshold
1
1
Unstable
1
1
Difficult to Advance
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
284
285
No Code Available
70
70
No Known Impact Or Consequence To Patient
61
61
Pain
52
52
Failure of Implant
46
46
Insufficient Information
38
38
Non-union Bone Fracture
32
32
Nerve Damage
27
27
Unspecified Infection
22
22
Bone Fracture(s)
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Post Operative Wound Infection
18
18
Dysphagia/ Odynophagia
16
16
Unspecified Tissue Injury
16
16
No Consequences Or Impact To Patient
15
15
Osteolysis
14
14
Hematoma
14
14
Injury
11
11
Cerebrospinal Fluid Leakage
9
9
Paralysis
8
8
Perforation of Vessels
7
7
Foreign Body In Patient
6
6
Neck Pain
6
6
Physical Asymmetry
5
5
Therapeutic Effects, Unexpected
5
5
Blood Loss
5
5
Abscess
4
4
Spinal Cord Injury
4
4
Loss of consciousness
3
3
Nervous System Injury
3
3
Peripheral Nervous Injury
3
3
Hemorrhage/Bleeding
3
3
Neuropathy
3
3
Hypersensitivity/Allergic reaction
3
3
Stenosis
3
3
Discomfort
2
2
Visual Impairment
2
2
Reaction
2
2
Laceration(s)
2
2
Oversedation
2
2
Pneumonia
2
2
Edema
2
2
Vertebral Fracture
2
2
Unspecified Vascular Problem
2
2
Renal Impairment
1
1
Paresthesia
1
1
Unspecified Nervous System Problem
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Thrombosis/Thrombus
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Cancer
1
1
Swelling/ Edema
1
1
Extravasation
1
1
Fall
1
1
Fatigue
1
1
Fever
1
1
Fistula
1
1
Hemothorax
1
1
Aspiration/Inhalation
1
1
Autoimmune Disorder
1
1
Erosion
1
1
Cyst(s)
1
1
Death
1
1
Wound Dehiscence
1
1
Ossification
1
1
Seroma
1
1
Shock
1
1
Skin Irritation
1
1
Spinal Column Injury
1
1
Paresis
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
Nausea
1
1
Hypovolemic Shock
1
1
Neurological Deficit/Dysfunction
1
1
Numbness
1
1
Depression
1
1
Paraplegia
1
1
Choking
1
1
Respiratory Failure
1
1
Ambulation Difficulties
1
1
Confusion/ Disorientation
1
1
Abdominal Distention
1
1
Ptosis
1
1
No Patient Involvement
1
1
Osteopenia/ Osteoporosis
1
1
Bowel Perforation
1
1
Tissue Breakdown
1
1
Decreased Sensitivity
1
1
Impaired Healing
1
1
Inadequate Pain Relief
1
1
Perforation of Esophagus
1
1
Tissue Damage
1
1
Urinary Retention
1
1
Urinary Tract Infection
1
1
Rupture
1
1
Myalgia
1
1
Hernia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
NuVasive Inc
II
Dec-20-2022
2
Synthes (USA) Products LLC
III
Nov-05-2020
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