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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone cement, posterior screw augmentation
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Definition The device is intended to augment the fixation of screws in a posterior spinal system construct.
Product CodePML
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 32 32
2022 12 13
2023 18 19
2024 60 61
2025 56 56
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 51 51
Break 46 48
Migration 21 21
Backflow 16 16
Leak/Splash 14 14
Entrapment of Device 11 13
Material Twisted/Bent 7 7
Device Slipped 6 6
No Apparent Adverse Event 5 5
Device Dislodged or Dislocated 4 4
Device-Device Incompatibility 3 3
Insufficient Information 3 3
Expiration Date Error 3 3
Compatibility Problem 2 2
Unintended Movement 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Mechanics Altered 2 2
Material Deformation 2 2
Product Quality Problem 2 2
Detachment of Device or Device Component 2 3
Fracture 2 2
Mechanical Jam 2 2
Mechanical Problem 1 1
Malposition of Device 1 1
Crack 1 1
Difficult to Advance 1 1
Use of Device Problem 1 1
Improper Flow or Infusion 1 1
Device Handling Problem 1 1
Failure to Infuse 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 79 81
Insufficient Information 27 27
Osteolysis 16 16
Pain 11 11
Foreign Body In Patient 11 12
Nerve Damage 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Post Operative Wound Infection 7 7
Pulmonary Embolism 7 7
Hypersensitivity/Allergic reaction 7 7
Failure of Implant 7 8
Unspecified Infection 7 7
Impaired Healing 6 6
Joint Laxity 5 5
Non-union Bone Fracture 3 3
Extravasation 2 2
Bone Fracture(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Tissue Injury 2 2
Metal Related Pathology 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Cardiac Arrest 1 1
Paralysis 1 1
Loss of consciousness 1 1
Paraplegia 1 1
Inadequate Osseointegration 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Icotec Ag II Jan-10-2024
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