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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 2
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 5
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
2018 1292 1292
2019 2303 2303
2020 1293 1293
2021 781 781
2022 471 471
2023 477 477
2024 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 3444 3444
Adverse Event Without Identified Device or Use Problem 1225 1225
Loosening of Implant Not Related to Bone-Ingrowth 387 387
Loose or Intermittent Connection 254 254
Insufficient Information 215 215
Chemical Problem 176 176
Unsealed Device Packaging 171 171
Appropriate Term/Code Not Available 139 139
Migration or Expulsion of Device 117 117
Loss of Osseointegration 117 117
Device Damaged Prior to Use 86 86
Device Difficult to Setup or Prepare 71 71
Tear, Rip or Hole in Device Packaging 68 68
Migration 64 64
Patient Device Interaction Problem 61 61
Break 61 61
Failure To Adhere Or Bond 51 51
Packaging Problem 50 50
Unstable 46 46
Device Contaminated During Manufacture or Shipping 43 43
Improper Chemical Reaction 41 41
Failure to Eject 41 41
Fracture 38 38
Expiration Date Error 30 30
Device Operates Differently Than Expected 29 29
Osseointegration Problem 24 24
Defective Device 22 22
Fluid/Blood Leak 21 21
Noise, Audible 19 19
Difficult to Open or Remove Packaging Material 16 16
Use of Device Problem 15 15
Improper or Incorrect Procedure or Method 15 15
Infusion or Flow Problem 14 14
Off-Label Use 12 12
Delivered as Unsterile Product 12 12
Missing Information 11 11
No Apparent Adverse Event 10 10
Material Integrity Problem 10 10
Failure to Osseointegrate 10 10
Contamination /Decontamination Problem 8 8
Leak/Splash 8 8
Mechanical Problem 8 8
Material Deformation 8 8
Naturally Worn 7 7
Device Handling Problem 7 7
Unintended Movement 7 7
Device Packaging Compromised 7 7
Patient-Device Incompatibility 6 6
Product Quality Problem 6 6
Coagulation in Device or Device Ingredient 6 6
Clumping in Device or Device Ingredient 5 5
Material Discolored 5 5
Incomplete or Missing Packaging 5 5
Detachment of Device or Device Component 5 5
Physical Resistance/Sticking 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Dislodged or Dislocated 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Too Rigid or Stiff 4 4
Crack 4 4
Contamination 4 4
Material Fragmentation 3 3
Difficult to Insert 3 3
Shipping Damage or Problem 3 3
Failure to Advance 3 3
Sharp Edges 3 3
Material Split, Cut or Torn 3 3
Material Twisted/Bent 3 3
Activation Problem 3 3
Compatibility Problem 2 2
Output Problem 2 2
Optical Discoloration 2 2
Biocompatibility 2 2
Device Ingredient or Reagent Problem 2 2
Device Operational Issue 2 2
Defective Component 2 2
Component Missing 2 2
Disassembly 2 2
Premature Activation 2 2
Device Emits Odor 2 2
Unintended System Motion 2 2
Material Erosion 2 2
Fire 2 2
Disconnection 2 2
Material Disintegration 1 1
Entrapment of Device 1 1
Degraded 1 1
Use of Incorrect Control/Treatment Settings 1 1
Computer Software Problem 1 1
Failure to Back-Up 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Misassembled 1 1
Nonstandard Device 1 1
Fitting Problem 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3232 3232
Pain 2938 2938
No Consequences Or Impact To Patient 588 588
Adhesion(s) 497 497
Edema 462 462
Unspecified Infection 454 454
Not Applicable 443 443
No Clinical Signs, Symptoms or Conditions 441 441
Insufficient Information 312 312
Swelling/ Edema 230 230
Joint Laxity 216 216
Synovitis 207 207
Loss of Range of Motion 191 191
Swelling 164 164
Limited Mobility Of The Implanted Joint 163 163
Discomfort 159 159
Ambulation Difficulties 147 147
Muscular Rigidity 143 143
Injury 142 142
No Known Impact Or Consequence To Patient 129 129
Failure of Implant 127 127
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 119 119
Fall 101 101
Osteolysis 98 98
Inflammation 92 92
Joint Disorder 90 90
Inadequate Osseointegration 81 81
Fibrosis 57 57
No Information 55 55
Scar Tissue 54 54
Hypersensitivity/Allergic reaction 50 50
Pulmonary Embolism 47 47
Tissue Damage 46 46
Cardiac Arrest 42 42
Wound Dehiscence 38 38
Necrosis 38 38
Scarring 36 36
Hematoma 34 34
Weakness 33 33
Unspecified Tissue Injury 32 32
Thrombosis 31 31
Hemorrhage/Bleeding 31 31
Cyst(s) 30 30
Bone Fracture(s) 26 26
No Patient Involvement 25 25
Local Reaction 24 24
Implant Pain 24 24
Death 21 21
Fatigue 20 20
Foreign Body Reaction 20 20
Erythema 19 19
Low Blood Pressure/ Hypotension 19 19
Deformity/ Disfigurement 19 19
Arthralgia 17 17
Fluid Discharge 16 16
Thrombosis/Thrombus 16 16
Post Operative Wound Infection 16 16
Muscle/Tendon Damage 16 16
Impaired Healing 15 15
Sepsis 12 12
Nerve Damage 12 12
Fever 12 12
Hypoesthesia 11 11
Non-union Bone Fracture 11 11
Reaction 10 10
Blood Loss 9 9
Numbness 8 8
Cellulitis 8 8
Abscess 8 8
Ossification 7 7
Erosion 7 7
Pulmonary Edema 7 7
Myocardial Infarction 7 7
Joint Dislocation 7 7
Perforation of Vessels 7 7
Anxiety 7 7
Patient Problem/Medical Problem 7 7
Pocket Erosion 6 6
Arthritis 6 6
Anemia 6 6
Stroke/CVA 6 6
Unspecified Musculoskeletal problem 6 6
Embolism/Embolus 6 6
Infarction, Cerebral 5 5
Dyspnea 5 5
Bacterial Infection 5 5
Rash 5 5
Pneumonia 4 4
Cerebrospinal Fluid Leakage 4 4
Foreign Body In Patient 4 4
Osteopenia/ Osteoporosis 4 4
Burning Sensation 4 4
Depression 4 4
Metal Related Pathology 4 4
Joint Contracture 4 4
Malunion of Bone 3 3
Renal Impairment 3 3
Urinary Tract Infection 3 3
Respiratory Distress 3 3
Respiratory Failure 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
4 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
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