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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
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 51 51
Break 51 53
Migration 25 25
Backflow 20 20
Leak/Splash 16 16
Entrapment of Device 11 13
Material Twisted/Bent 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Device Slipped 6 6
No Apparent Adverse Event 5 5
Fracture 5 5
Device-Device Incompatibility 4 4
Device Dislodged or Dislocated 4 4
Insufficient Device Problem Information 3 3
Expiration Date Error 3 3
Detachment of Device or Device Component 2 3
Compatibility Problem 2 2
Material Deformation 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Unintended Movement 2 2
Product Quality Problem 2 2
Difficult to Advance 1 1
Improper Flow or Infusion 1 1
Device Handling Problem 1 1
Thickening of Material 1 1
Use of Device Problem 1 1
Failure to Infuse 1 1
Malposition of Device 1 1
Crack 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 95 97
Insufficient Information 29 29
Osteolysis 16 16
Pain 14 14
Foreign Body In Patient 11 12
Nerve Damage 10 10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 8 8
Post Operative Wound Infection 7 7
Unspecified Infection 7 7
Pulmonary Embolism 7 7
Hypersensitivity/Allergic reaction 7 7
Failure of Implant 7 8
Impaired Healing 6 6
Joint Laxity 5 5
Extravasation 3 3
Device Embedded In Tissue or Plaque 3 3
Nonunion/Delayed-union Bone Fracture 3 3
Unspecified Tissue Injury 2 2
Bone Fracture(s) 2 2
Metal Related Pathology 1 1
Inadequate Osseointegration 1 1
Hematoma 1 1
Vertebral Fracture 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Cardiac Arrest 1 1
Loss of consciousness 1 1
Paralysis 1 1
Paraplegia 1 1

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