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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone cement
Product CodeLOD
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMECANICA INDUSTRIA E COMERCIODE PRODUTOS ORTOPEDICOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
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
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