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TPLC
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Device
spinal vertebral body replacement device
Regulation Description
Spinal intervertebral body fixation orthosis.
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
CORELINK, LLC
SUBSTANTIALLY EQUIVALENT
1
FOUNDATION SURGICAL GROUP, INC.
SUBSTANTIALLY EQUIVALENT
1
ICOTEC AG
SUBSTANTIALLY EQUIVALENT
2
NUVASIVE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
SIGNATURE ORTHOPAEDICS PTY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
157
157
2021
208
208
2022
137
138
2023
71
71
2024
97
97
2025
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
170
170
Migration
99
99
Break
72
72
Mechanics Altered
63
63
Material Deformation
40
41
Mechanical Problem
39
39
Insufficient Information
29
29
Collapse
29
29
Activation Failure
27
27
Mechanical Jam
24
24
No Apparent Adverse Event
18
18
Patient Device Interaction Problem
18
18
Material Integrity Problem
16
16
Fracture
14
14
Device Dislodged or Dislocated
12
12
Compatibility Problem
12
12
Detachment of Device or Device Component
10
10
Migration or Expulsion of Device
10
10
Connection Problem
8
8
Material Twisted/Bent
8
8
Malposition of Device
8
8
Unintended Movement
7
7
Activation Problem
7
7
Use of Device Problem
6
6
Appropriate Term/Code Not Available
5
5
Material Separation
4
4
Output Problem
4
4
Failure to Advance
4
4
Device Slipped
4
4
Device Damaged by Another Device
3
3
Scratched Material
3
3
Product Quality Problem
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Noise, Audible
2
2
Improper or Incorrect Procedure or Method
2
2
Loose or Intermittent Connection
2
2
Positioning Failure
2
2
Premature Activation
2
2
Difficult to Remove
2
2
Activation, Positioning or Separation Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Naturally Worn
2
2
Degraded
2
2
Device-Device Incompatibility
1
1
Biocompatibility
1
1
Patient-Device Incompatibility
1
1
Structural Problem
1
1
Loss of Threshold
1
1
Difficult to Advance
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
334
335
Insufficient Information
67
67
Pain
47
47
No Known Impact Or Consequence To Patient
43
43
Failure of Implant
37
37
Non-union Bone Fracture
35
35
No Code Available
32
32
Bone Fracture(s)
24
24
Nerve Damage
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Post Operative Wound Infection
20
20
Unspecified Infection
18
18
Unspecified Tissue Injury
17
17
Hematoma
17
17
Dysphagia/ Odynophagia
16
16
Osteolysis
14
14
Cerebrospinal Fluid Leakage
12
12
Perforation of Vessels
8
8
Hemorrhage/Bleeding
8
8
No Consequences Or Impact To Patient
7
7
Neck Pain
6
6
Therapeutic Effects, Unexpected
5
5
Physical Asymmetry
5
5
Injury
5
5
Spinal Cord Injury
5
5
Blood Loss
4
4
Stenosis
4
4
Nervous System Injury
4
4
Paralysis
4
4
Thrombosis/Thrombus
3
3
Pneumothorax
3
3
Foreign Body In Patient
3
3
Loss of consciousness
3
3
Peripheral Nervous Injury
3
3
Neuropathy
3
3
Hypersensitivity/Allergic reaction
3
3
Abscess
2
2
Spinal Column Injury
2
2
Pleural Effusion
2
2
Oversedation
2
2
Laceration(s)
2
2
Ambulation Difficulties
2
2
Vertebral Fracture
2
2
Impaired Healing
2
2
Speech Disorder
2
2
Inadequate Osseointegration
2
2
Unspecified Vascular Problem
2
2
Unspecified Nervous System Problem
2
2
Hypovolemic Shock
1
1
Hemothorax
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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