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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement, antibiotic
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
G21 S.R.L
  SUBSTANTIALLY EQUIVALENT 3
G21 SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 330 330
2019 497 497
2020 375 375
2021 648 648
2022 275 275
2023 259 259
2024 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 842 842
Unsealed Device Packaging 452 452
Adverse Event Without Identified Device or Use Problem 398 398
Infusion or Flow Problem 182 182
Chemical Problem 153 153
Improper Chemical Reaction 130 130
Loosening of Implant Not Related to Bone-Ingrowth 71 71
Tear, Rip or Hole in Device Packaging 40 40
Patient Device Interaction Problem 39 39
Insufficient Information 39 39
Device Contaminated During Manufacture or Shipping 33 33
Device Damaged Prior to Use 31 31
Migration 29 29
Appropriate Term/Code Not Available 26 26
Difficult to Open or Remove Packaging Material 19 19
Loss of Osseointegration 15 15
Device Dislodged or Dislocated 14 14
Material Integrity Problem 12 12
Inaccurate Information 10 10
Expiration Date Error 10 10
Break 8 8
Packaging Problem 8 8
No Flow 8 8
Device Ingredient or Reagent Problem 8 8
Fracture 7 7
Loose or Intermittent Connection 7 7
Off-Label Use 6 6
Use of Device Problem 5 5
Patient-Device Incompatibility 5 5
Biocompatibility 5 5
Migration or Expulsion of Device 5 5
Delivered as Unsterile Product 4 4
Mechanical Problem 4 4
Clumping in Device or Device Ingredient 4 4
Material Discolored 4 4
Improper or Incorrect Procedure or Method 4 4
Incomplete or Missing Packaging 4 4
Improper Flow or Infusion 4 4
Output Problem 3 3
No Apparent Adverse Event 3 3
Coagulation in Device or Device Ingredient 3 3
Fluid/Blood Leak 3 3
Physical Resistance/Sticking 3 3
Leak/Splash 2 2
Fire 2 2
Failure To Adhere Or Bond 2 2
Unstable 2 2
Product Quality Problem 2 2
Malposition of Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Handling Problem 2 2
Naturally Worn 2 2
Device Disinfection Or Sterilization Issue 2 2
Contamination /Decontamination Problem 2 2
Device Packaging Compromised 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Detachment of Device or Device Component 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Activation Failure 1 1
Noise, Audible 1 1
Osseointegration Problem 1 1
Missing Information 1 1
Powder Leak 1 1
Material Too Soft/Flexible 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Shipping Damage or Problem 1 1
Failure to Osseointegrate 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Contamination 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 699 699
Pain 694 694
No Code Available 315 315
Insufficient Information 277 277
No Clinical Signs, Symptoms or Conditions 247 247
Adhesion(s) 209 209
Joint Laxity 172 172
Swelling/ Edema 149 149
Unspecified Infection 137 137
Synovitis 97 97
Loss of Range of Motion 91 91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 79 79
Failure of Implant 72 72
Ambulation Difficulties 65 65
Muscular Rigidity 62 62
Discomfort 60 60
Edema 52 52
Limited Mobility Of The Implanted Joint 41 41
No Patient Involvement 35 35
Fall 33 33
No Known Impact Or Consequence To Patient 31 31
Inflammation 29 29
Fatigue 21 21
No Information 19 19
Scar Tissue 18 18
Arthralgia 17 17
Joint Disorder 17 17
Weakness 15 15
Hypersensitivity/Allergic reaction 15 15
Cyst(s) 14 14
Not Applicable 14 14
Unspecified Tissue Injury 14 14
Thrombosis/Thrombus 13 13
Inadequate Osseointegration 13 13
Low Blood Pressure/ Hypotension 13 13
Injury 13 13
Swelling 13 13
Erythema 12 12
Foreign Body Reaction 12 12
Joint Contracture 12 12
Cardiac Arrest 11 11
Wound Dehiscence 11 11
Necrosis 10 10
Implant Pain 10 10
Local Reaction 9 9
Pulmonary Embolism 7 7
Bone Fracture(s) 7 7
Fibrosis 7 7
Joint Dislocation 7 7
Muscle/Tendon Damage 6 6
Hemorrhage/Bleeding 6 6
Bacterial Infection 6 6
Nerve Damage 6 6
Scarring 5 5
Thrombosis 5 5
Death 5 5
Embolism/Embolus 5 5
Impaired Healing 5 5
Numbness 5 5
Post Operative Wound Infection 4 4
Osteolysis 4 4
Unspecified Musculoskeletal problem 4 4
Bradycardia 4 4
Rash 4 4
Arthritis 3 3
Ischemia 3 3
Osteopenia/ Osteoporosis 3 3
Confusion/ Disorientation 2 2
Physical Asymmetry 2 2
Reaction to Medicinal Component of Device 2 2
Limb Fracture 2 2
Paresthesia 2 2
High Blood Pressure/ Hypertension 2 2
Hematoma 2 2
Fever 2 2
Non specific EKG/ECG Changes 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Erosion 2 2
Abscess 2 2
Neuropathy 2 2
Myocardial Infarction 2 2
Skin Discoloration 2 2
Hip Fracture 2 2
Deformity/ Disfigurement 2 2
Burning Sensation 2 2
Discharge 2 2
Cardiogenic Shock 1 1
Anxiety 1 1
Distress 1 1
Hot Flashes/Flushes 1 1
Brain Injury 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Hypoesthesia 1 1
Seroma 1 1
Tissue Damage 1 1
Vomiting 1 1
Tachycardia 1 1
Nausea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Nov-15-2022
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