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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 148
Material Integrity Problem 19 19
Delivered as Unsterile Product 19 19
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
Use of Device Problem 1 1
Melted 1 1
Fungus in Device Environment 1 1
Incomplete or Missing Packaging 1 1
Migration or Expulsion of Device 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Unspecified Infection 21 21
No Consequences Or Impact To Patient 12 12
Inflammation 8 8
Insufficient Information 6 128
Not Applicable 4 4
No Code Available 4 4
Hearing Impairment 3 3
Injury 3 3
Erythema 3 3
Cerebrospinal Fluid Leakage 3 247
Skin Inflammation/ Irritation 2 2
Foreign Body Reaction 2 2
No Known Impact Or Consequence To Patient 2 2
Paralysis 2 2
Pain 2 2
Fluid Discharge 2 2
Swelling/ Edema 2 2
Bacterial Infection 2 2
Hemorrhage/Bleeding 2 2
Impaired Healing 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Decreased Sensitivity 1 1
Radiation Exposure, Unintended 1 1
Memory Loss/Impairment 1 1
Cyst(s) 1 1
Hematoma 1 1
Implant Pain 1 1
Post Operative Wound Infection 1 1
Fever 1 1
Visual Disturbances 1 1
Thrombosis 1 1
Discomfort 1 1
No Patient Involvement 1 1
Headache 1 1
Tinnitus 1 1
Meningitis 1 1

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