• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device methyl methacrylate for cranioplasty
Regulation Description Methyl methacrylate for cranioplasty.
Product CodeGXP
Regulation Number 882.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
DIMENSIONAL BIOCERAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL KINETICS, LLC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 17 17
2017 16 16
2018 9 9
2019 9 9
2020 31 31
2021 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 50
Insufficient Information 7 7
Break 6 6
Fracture 4 4
Migration 4 4
Device Operational Issue 3 3
Crack 2 2
Fluid Leak 2 2
Migration or Expulsion of Device 2 2
Device Contamination with Chemical or Other Material 2 2
Failure To Adhere Or Bond 2 2
Contamination 1 1
Material Erosion 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Loss of Osseointegration 1 1
Chemical Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Improper Chemical Reaction 1 1
Positioning Problem 1 1
Microbial Contamination of Device 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Loss of or Failure to Bond 1 1
Device Expiration Issue 1 1
Temperature Problem 1 1
Material Fragmentation 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 21 21
Unspecified Infection 20 20
Post Operative Wound Infection 16 16
No Known Impact Or Consequence To Patient 16 16
Pain 15 15
Inflammation 10 10
Cerebrospinal Fluid Leakage 9 9
Impaired Healing 8 8
Headache 4 4
No Consequences Or Impact To Patient 4 4
Neurological Deficit/Dysfunction 3 3
Swelling 3 3
Wound Dehiscence 3 3
Skin Inflammation 3 3
No Information 3 3
Dizziness 2 2
Device Embedded In Tissue or Plaque 2 2
Meningitis 2 2
Reaction 2 2
Visual Impairment 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Hearing Impairment 2 2
Hearing Loss 1 1
Abscess 1 1
Numbness 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Vomiting 1 1
Weakness 1 1
Pocket Erosion 1 1
Facial Nerve Paralysis 1 1
Nausea 1 1
Post Traumatic Wound Infection 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Skeletal Kinetics, Llc II Jan-15-2021
2 Skeletal Kinetics, Llc II Jul-15-2020
3 Skeletal Kinetics, Llc II May-20-2020
4 Stryker Leibinger GmbH & Co. KG II Apr-19-2021
-
-