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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 6

MDR Year MDR Reports MDR Events
2020 16 16
2021 12 378
2022 31 31
2023 20 20
2024 32 32
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 31 31
Adverse Event Without Identified Device or Use Problem 22 144
Delivered as Unsterile Product 20 20
Biocompatibility 14 14
Device Markings/Labelling Problem 8 8
Device Contaminated During Manufacture or Shipping 5 5
Appropriate Term/Code Not Available 5 5
Defective Device 3 247
Manufacturing, Packaging or Shipping Problem 3 3
Contamination /Decontamination Problem 2 2
Material Discolored 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Fungus in Device Environment 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58 58
Unspecified Infection 22 22
Inflammation 6 6
Insufficient Information 6 128
Cerebrospinal Fluid Leakage 4 248
No Consequences Or Impact To Patient 4 4
Hearing Impairment 3 3
Injury 3 3
Skin Inflammation/ Irritation 2 2
Paralysis 2 2
Erythema 2 2
Pain 2 2
Fluid Discharge 2 2
Swelling/ Edema 2 2
Impaired Healing 1 1
Patient Problem/Medical Problem 1 1
Hypersensitivity/Allergic reaction 1 1
Decreased Sensitivity 1 1
Not Applicable 1 1
No Code Available 1 1
Cyst(s) 1 1
Implant Pain 1 1
Foreign Body Reaction 1 1
Post Operative Wound Infection 1 1
Unspecified Nervous System Problem 1 1
Fever 1 1
Visual Disturbances 1 1
Discomfort 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Meningitis 1 1

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