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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
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
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 2
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 35 35
2020 27 27
2021 32 32
2022 12 12
2023 18 18
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 51 51
Adverse Event Without Identified Device or Use Problem 50 50
Migration 17 17
Loose or Intermittent Connection 15 15
Entrapment of Device 11 11
Device Slipped 10 10
Material Twisted/Bent 6 6
Device-Device Incompatibility 4 4
Detachment of Device or Device Component 4 4
No Apparent Adverse Event 4 4
Disconnection 3 3
Crack 3 3
Insufficient Information 3 3
Expiration Date Error 3 3
Leak/Splash 2 2
Compatibility Problem 2 2
Mechanical Problem 2 2
Difficult to Advance 1 1
Backflow 1 1
Improper Flow or Infusion 1 1
Failure to Infuse 1 1
Device Dislodged or Dislocated 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
No Code Available 39 39
Failure of Implant 22 22
Insufficient Information 22 22
Foreign Body In Patient 13 13
Osteolysis 13 13
Unspecified Infection 10 10
Nerve Damage 10 10
Pain 10 10
No Consequences Or Impact To Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Hypersensitivity/Allergic reaction 7 7
Post Operative Wound Infection 7 7
Impaired Healing 6 6
Joint Laxity 5 5
No Known Impact Or Consequence To Patient 4 4
Tissue Damage 4 4
Non-union Bone Fracture 3 3
Unspecified Tissue Injury 3 3
Bone Fracture(s) 2 2
Spinal Column Injury 2 2
Metal Related Pathology 1 1
Hematoma 1 1
Paralysis 1 1
Extravasation 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

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