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
bone cement
Product Code
LOD
Regulation Number
888.3027
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMECANICA INDUSTRIA E COMERCIODE PRODUTOS ORTOPEDICOS LTDA
SUBSTANTIALLY EQUIVALENT
1
1. K212729
Bone Cement-Normal Viscosity
G21 S.R.L
SUBSTANTIALLY EQUIVALENT
2
G21 S.R.L.
SUBSTANTIALLY EQUIVALENT
1
HERAEUS MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
4
ORMED GRUP MEDIKAL TURIZM SAGLIK HIZMETLERI SANAYI VE
SUBSTANTIALLY EQUIVALENT
1
OSARTIS GMBH
SUBSTANTIALLY EQUIVALENT
5
OSTEOREMEDIES, LLC
SUBSTANTIALLY EQUIVALENT
1
TECRES S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2303
2303
2020
1293
1293
2021
781
781
2022
471
471
2023
477
477
2024
113
113
Device Problems
MDRs with this Device Problem
Events in those MDRs
Loss of or Failure to Bond
2889
2889
Adverse Event Without Identified Device or Use Problem
1218
1218
Loosening of Implant Not Related to Bone-Ingrowth
344
344
Chemical Problem
181
181
Unsealed Device Packaging
147
147
Loss of Osseointegration
110
110
Device Damaged Prior to Use
79
79
Insufficient Information
76
76
Appropriate Term/Code Not Available
71
71
Patient Device Interaction Problem
63
63
Tear, Rip or Hole in Device Packaging
63
63
Device Difficult to Setup or Prepare
62
62
Migration or Expulsion of Device
59
59
Migration
54
54
Loose or Intermittent Connection
51
51
Device Contaminated During Manufacture or Shipping
40
40
Failure to Eject
40
40
Unstable
34
34
Break
33
33
Fracture
31
31
Packaging Problem
29
29
Improper Chemical Reaction
29
29
Expiration Date Error
29
29
Osseointegration Problem
24
24
Fluid/Blood Leak
21
21
Improper or Incorrect Procedure or Method
16
16
Difficult to Open or Remove Packaging Material
13
13
Noise, Audible
13
13
Off-Label Use
12
12
Material Integrity Problem
11
11
Missing Information
11
11
No Apparent Adverse Event
10
10
Failure to Osseointegrate
10
10
Use of Device Problem
9
9
Mechanical Problem
8
8
Contamination /Decontamination Problem
8
8
Defective Device
7
7
Delivered as Unsterile Product
7
7
Device Handling Problem
7
7
Unintended Movement
7
7
Product Quality Problem
5
5
Coagulation in Device or Device Ingredient
5
5
Patient-Device Incompatibility
5
5
Incomplete or Missing Packaging
5
5
Device Dislodged or Dislocated
4
4
Device Ingredient or Reagent Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Detachment of Device or Device Component
3
3
Activation Problem
3
3
Material Twisted/Bent
3
3
Naturally Worn
3
3
Material Discolored
3
3
Material Fragmentation
3
3
Difficult to Insert
2
2
Leak/Splash
2
2
Contamination
2
2
Crack
2
2
Entrapment of Device
2
2
Material Erosion
2
2
Fire
2
2
Clumping in Device or Device Ingredient
2
2
Unintended System Motion
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Deformation
2
2
Output Problem
2
2
Compatibility Problem
2
2
Premature Activation
2
2
Defective Component
2
2
Component Missing
2
2
Biocompatibility
2
2
Material Split, Cut or Torn
2
2
Ejection Problem
1
1
Physical Resistance/Sticking
1
1
Sharp Edges
1
1
Non Reproducible Results
1
1
Device Difficult to Maintain
1
1
Activation, Positioning or Separation Problem
1
1
Malposition of Device
1
1
Fumes or Vapors
1
1
Inaccurate Delivery
1
1
Infusion or Flow Problem
1
1
Installation-Related Problem
1
1
Device Markings/Labelling Problem
1
1
Device-Device Incompatibility
1
1
Temperature Problem
1
1
Peeled/Delaminated
1
1
Misassembled
1
1
Nonstandard Device
1
1
Difficult to Remove
1
1
Material Too Rigid or Stiff
1
1
Problem with Sterilization
1
1
Unexpected Therapeutic Results
1
1
Material Puncture/Hole
1
1
Computer Software Problem
1
1
Degraded
1
1
Failure to Back-Up
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
2826
2826
Pain
2460
2460
Adhesion(s)
478
478
No Clinical Signs, Symptoms or Conditions
449
449
Edema
422
422
Unspecified Infection
400
400
Insufficient Information
326
326
No Consequences Or Impact To Patient
277
277
Swelling/ Edema
239
239
Joint Laxity
220
220
Loss of Range of Motion
172
172
Synovitis
166
166
Limited Mobility Of The Implanted Joint
155
155
Discomfort
140
140
Muscular Rigidity
140
140
Ambulation Difficulties
134
134
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
120
120
Failure of Implant
119
119
Swelling
109
109
Injury
101
101
Fall
86
86
Inflammation
84
84
Inadequate Osseointegration
73
73
Osteolysis
72
72
Joint Disorder
53
53
No Known Impact Or Consequence To Patient
52
52
Not Applicable
52
52
Fibrosis
51
51
Hypersensitivity/Allergic reaction
47
47
Scar Tissue
46
46
Pulmonary Embolism
44
44
Tissue Damage
43
43
Unspecified Tissue Injury
38
38
Wound Dehiscence
37
37
Necrosis
35
35
Scarring
34
34
Hematoma
33
33
Hemorrhage/Bleeding
32
32
Cardiac Arrest
31
31
Thrombosis
31
31
Weakness
28
28
Cyst(s)
27
27
Bone Fracture(s)
25
25
Implant Pain
25
25
No Information
24
24
Local Reaction
23
23
Thrombosis/Thrombus
22
22
Fatigue
20
20
Erythema
19
19
Arthralgia
19
19
Deformity/ Disfigurement
18
18
Foreign Body Reaction
18
18
Low Blood Pressure/ Hypotension
17
17
Post Operative Wound Infection
16
16
Fluid Discharge
16
16
Muscle/Tendon Damage
16
16
Impaired Healing
14
14
Nerve Damage
13
13
Sepsis
12
12
Non-union Bone Fracture
11
11
Fever
10
10
Death
10
10
Hypoesthesia
9
9
No Patient Involvement
9
9
Cellulitis
8
8
Abscess
8
8
Ossification
7
7
Pulmonary Edema
7
7
Myocardial Infarction
7
7
Blood Loss
7
7
Numbness
7
7
Perforation of Vessels
7
7
Anxiety
7
7
Reaction
6
6
Embolism/Embolus
6
6
Pocket Erosion
6
6
Anemia
6
6
Arthritis
6
6
Erosion
6
6
Unspecified Musculoskeletal problem
6
6
Bacterial Infection
5
5
Stroke/CVA
5
5
Infarction, Cerebral
5
5
Purulent Discharge
5
5
Joint Dislocation
5
5
Joint Contracture
4
4
Osteopenia/ Osteoporosis
4
4
Patient Problem/Medical Problem
4
4
Dyspnea
4
4
Cerebrospinal Fluid Leakage
4
4
Rash
4
4
Metal Related Pathology
4
4
Paralysis
3
3
Pneumonia
3
3
Respiratory Distress
3
3
Nausea
3
3
Chest Pain
3
3
Test Result
3
3
Device Embedded In Tissue or Plaque
3
3
Malunion of Bone
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
BIOPSYBELL S.R.L.
II
May-19-2021
2
Howmedica Osteonics Corp.
III
Dec-20-2022
3
Smith & Nephew, Inc.
II
Jan-29-2021
-
-