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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device methyl methacrylate for cranioplasty
Regulation Description Methyl methacrylate for cranioplasty.
Product CodeGXP
Regulation Number 882.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 12
Device Operational Issue 3
Fracture 3
Break 2
Migration or Expulsion of Device 2
Failure To Adhere Or Bond 2
Device Operates Differently Than Expected 2
Device Contamination with Chemical or Other Material 1
Coagulation in Device or device Ingredient 1
Device Expiration Issue 1
Loss of or Failure to Bond 1
Defective Device 1
Use of Device Problem 1
Migration 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 34

Recalls
Manufacturer Recall Class Date Posted
1 Skeletal Kinetics, Llc II Jul-15-2020
2 Skeletal Kinetics, Llc II May-20-2020

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