Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 wax, bone
Product CodeMTJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCON, INC.
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2019 17 17
2020 16 16
2021 12 378
2022 31 31
2023 20 20
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 147
Delivered as Unsterile Product 17 17
Material Integrity Problem 17 17
Biocompatibility 14 14
Device Markings/Labelling Problem 8 8
Loss of or Failure to Bond 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Contaminated During Manufacture or Shipping 4 4
Contamination /Decontamination Problem 3 3
Defective Device 3 247
Patient-Device Incompatibility 2 2
Melted 1 1
Migration or Expulsion of Device 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Incomplete or Missing Packaging 1 1
Fungus in Device Environment 1 1
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Unspecified Infection 20 20
No Consequences Or Impact To Patient 12 12
Inflammation 8 8
Insufficient Information 6 128
Not Applicable 4 4
No Code Available 4 4
Injury 3 3
Cerebrospinal Fluid Leakage 3 247
Erythema 3 3
Hearing Impairment 3 3
Foreign Body Reaction 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Paralysis 2 2
Fluid Discharge 2 2
Skin Inflammation/ Irritation 2 2
No Known Impact Or Consequence To Patient 2 2
Bacterial Infection 2 2
Swelling/ Edema 2 2
Radiation Exposure, Unintended 1 1
Implant Pain 1 1
Patient Problem/Medical Problem 1 1
Discomfort 1 1
Impaired Healing 1 1
Meningitis 1 1
Post Operative Wound Infection 1 1
No Patient Involvement 1 1
Decreased Sensitivity 1 1
Thrombosis 1 1
Tinnitus 1 1
Visual Disturbances 1 1
Hypersensitivity/Allergic reaction 1 1
Memory Loss/Impairment 1 1
Headache 1 1
Hematoma 1 1
Fever 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jan-05-2024
-
-