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TPLC
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Device
cement, bone, vertebroplasty
Product Code
NDN
Regulation Number
888.3027
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOPSYBELL S.R.L.
SUBSTANTIALLY EQUIVALENT
1
BONWRX LTD
SUBSTANTIALLY EQUIVALENT
1
DEPUY SPINE, INC.
SUBSTANTIALLY EQUIVALENT
1
GS MEDICAL CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
GS MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HYPREVENTION
SUBSTANTIALLY EQUIVALENT
1
HYPREVENTION SAS
SUBSTANTIALLY EQUIVALENT
1
JOLINE GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
NINGBO HICREN BIOTECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SLK ORTHO LLC
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
STRYKER INSTRUMENTS
SUBSTANTIALLY EQUIVALENT
2
TECRES S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
227
227
2020
212
212
2021
344
344
2022
270
271
2023
311
315
2024
121
121
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
230
230
Improper Chemical Reaction
195
195
Leak/Splash
171
171
Chemical Problem
151
151
Migration or Expulsion of Device
142
142
Fluid/Blood Leak
133
133
Material Integrity Problem
92
92
Failure to Eject
87
87
Migration
81
81
Inflation Problem
66
66
Break
55
55
Coagulation in Device or Device Ingredient
25
25
Appropriate Term/Code Not Available
23
23
No Apparent Adverse Event
18
18
Fracture
18
20
Compatibility Problem
16
16
Entrapment of Device
14
14
Packaging Problem
12
12
Insufficient Information
11
11
Activation Failure
10
11
Difficult or Delayed Separation
10
12
Activation, Positioning or Separation Problem
10
10
Separation Failure
9
9
Device-Device Incompatibility
5
5
Device Handling Problem
5
5
Difficult to Remove
5
5
Crack
5
5
Clumping in Device or Device Ingredient
4
4
Mechanical Problem
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Patient Device Interaction Problem
4
4
Device Difficult to Maintain
4
4
Pressure Problem
3
3
Device Damaged Prior to Use
3
3
Product Quality Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Expiration Date Error
3
3
Device Difficult to Setup or Prepare
3
3
Excess Flow or Over-Infusion
3
3
Deflation Problem
3
3
Material Rupture
2
2
Material Separation
2
2
Mechanics Altered
2
2
Inaccurate Information
2
2
Detachment of Device or Device Component
2
2
Device Ingredient or Reagent Problem
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Patient-Device Incompatibility
1
1
Biocompatibility
1
1
Contamination /Decontamination Problem
1
1
Component or Accessory Incompatibility
1
1
Positioning Problem
1
1
Osseointegration Problem
1
1
Output Problem
1
1
Mechanical Jam
1
1
Short Fill
1
1
Problem with Sterilization
1
1
Off-Label Use
1
1
Misassembled
1
1
Nonstandard Device
1
1
Component Missing
1
1
Failure to Discharge
1
1
Material Discolored
1
1
Backflow
1
1
Loss of or Failure to Bond
1
1
Material Fragmentation
1
1
Use of Incorrect Control/Treatment Settings
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
727
732
Extravasation
132
132
No Known Impact Or Consequence To Patient
110
110
No Consequences Or Impact To Patient
104
104
Insufficient Information
83
84
Pain
58
58
Bone Fracture(s)
58
58
No Code Available
52
52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
37
37
Nerve Damage
37
37
Foreign Body In Patient
30
30
Unspecified Tissue Injury
27
27
Pulmonary Embolism
25
25
Non-union Bone Fracture
23
23
Osteolysis
22
22
Hematoma
22
22
Post Operative Wound Infection
22
22
Failure of Implant
20
20
Unspecified Infection
18
18
Joint Laxity
17
17
Injury
16
16
Embolism/Embolus
14
14
Decreased Sensitivity
10
10
No Patient Involvement
9
9
Spinal Cord Injury
9
9
Vertebral Fracture
9
9
Perforation of Vessels
9
9
Cardiac Arrest
9
9
Dyspnea
9
9
Death
8
8
Cerebrospinal Fluid Leakage
8
8
Arrhythmia
7
7
Necrosis
7
7
Paralysis
7
7
Weakness
6
6
Stenosis
6
6
Chest Pain
6
6
Device Embedded In Tissue or Plaque
6
6
Neck Pain
5
5
Physical Asymmetry
5
5
Hypersensitivity/Allergic reaction
5
5
Impaired Healing
5
5
Pneumonia
4
4
Neurological Deficit/Dysfunction
4
4
Dysphagia/ Odynophagia
4
4
Swelling/ Edema
4
4
Ambulation Difficulties
4
4
Paraplegia
3
3
Pleural Effusion
3
3
Thrombosis/Thrombus
3
3
Unspecified Nervous System Problem
3
3
Cancer
3
3
Low Blood Pressure/ Hypotension
3
3
Inflammation
3
3
Muscle Weakness
3
3
Loss of Range of Motion
3
3
Numbness
3
3
Paresis
2
2
Spinal Column Injury
2
2
Tissue Damage
2
2
Myocardial Infarction
2
2
Hypoxia
2
2
Fever
2
2
Hemorrhage/Bleeding
2
2
Edema
2
2
Stroke/CVA
2
2
Wound Dehiscence
2
2
Bacterial Infection
2
2
Adult Respiratory Distress Syndrome
2
2
Speech Disorder
2
2
Ischemia Stroke
2
2
Foreign Body Embolism
2
2
Thromboembolism
2
2
Not Applicable
2
2
Blood Loss
2
2
Sudden Cardiac Death
2
2
Implant Pain
2
2
Cardiac Perforation
1
1
Sleep Dysfunction
1
1
Pseudoaneurysm
1
1
Respiratory Failure
1
1
Fluid Discharge
1
1
Osteopenia/ Osteoporosis
1
1
Tricuspid Valve Insufficiency/ Regurgitation
1
1
Intervertebral Disc Compression or Protrusion
1
1
Unspecified Musculoskeletal problem
1
1
Paresthesia
1
1
Convulsion/Seizure
1
1
Peripheral Nervous Injury
1
1
Anaphylactic Shock
1
1
Anemia
1
1
Aspiration/Inhalation
1
1
Cyst(s)
1
1
Hemoptysis
1
1
Headache
1
1
Fall
1
1
Fatigue
1
1
High Blood Pressure/ Hypertension
1
1
Ischemia
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
May-05-2020
2
Stryker Spine
II
Jul-20-2021
3
TEKNIMED SAS
II
Feb-06-2023
4
Zavation
II
Jun-01-2021
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