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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
2
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
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
188
188
Migration
109
109
Break
74
74
Mechanics Altered
60
60
Material Deformation
36
37
Insufficient Information
28
28
Activation Failure
27
27
Mechanical Jam
23
23
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
Appropriate Term/Code Not Available
17
17
Patient Device Interaction Problem
17
17
Material Integrity Problem
16
16
Mechanical Problem
16
16
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
Material Separation
5
5
Device-Device Incompatibility
4
4
Output Problem
4
4
Scratched Material
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Device Damaged by Another Device
3
3
Material Fragmentation
3
3
Degraded
2
2
Positioning Failure
2
2
Premature Activation
2
2
Difficult to Insert
2
2
Loose or Intermittent Connection
2
2
Activation, Positioning or Separation Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Failure to Advance
2
2
Noise, Audible
2
2
Therapeutic or Diagnostic Output Failure
2
2
Naturally Worn
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Overcorrection
1
1
Physical Resistance/Sticking
1
1
Failure to Cut
1
1
Structural Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Loss of Threshold
1
1
Unstable
1
1
Patient-Device Incompatibility
1
1
Biocompatibility
1
1
Difficult to Advance
1
1
Loss of or Failure to Bond
1
1
Leak/Splash
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Unintended System Motion
1
1
Disconnection
1
1
Entrapment of Device
1
1
Inflation Problem
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
285
286
No Code Available
70
70
No Known Impact Or Consequence To Patient
61
61
Insufficient Information
55
55
Pain
52
52
Failure of Implant
50
50
Non-union Bone Fracture
33
33
Nerve Damage
28
28
Unspecified Infection
25
25
Bone Fracture(s)
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Post Operative Wound Infection
18
18
Dysphagia/ Odynophagia
17
17
Unspecified Tissue Injury
17
17
Hematoma
16
16
No Consequences Or Impact To Patient
15
15
Osteolysis
14
14
Injury
11
11
Cerebrospinal Fluid Leakage
10
10
Paralysis
8
8
Perforation of Vessels
8
8
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
Hemorrhage/Bleeding
4
4
Spinal Cord Injury
4
4
Loss of consciousness
3
3
Nervous System Injury
3
3
Thrombosis/Thrombus
3
3
Peripheral Nervous Injury
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
Speech Disorder
2
2
Unspecified Vascular Problem
2
2
Vertebral Fracture
2
2
Renal Impairment
1
1
Paresthesia
1
1
Unspecified Nervous System Problem
1
1
Unspecified Mental, Emotional or Behavioural Problem
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
Pulmonary Embolism
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
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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