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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, bone void, osteoinduction (w/o human growth factor)
Regulation Description Resorbable calcium salt bone void filler device.
Product CodeMBP
Regulation Number 888.3045
Device Class 2


Premarket Reviews
ManufacturerDecision
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 2 2
2022 4 4
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Patient-Device Incompatibility 2 2
Expiration Date Error 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Unsealed Device Packaging 1 1
Microbial Contamination of Device 1 1
Material Fragmentation 1 1
Component Missing 1 1
Inaccurate Information 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Swelling/ Edema 3 3
Unspecified Infection 2 2
Damage to Ligament(s) 2 2
Patient Problem/Medical Problem 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Bone Fracture(s) 2 2
Hematoma 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 2 2
Impaired Healing 1 1
Rheumatoid Arthritis 1 1
Emotional Changes 1 1
Fungal Infection 1 1
Inflammation 1 1
Muscle Weakness 1 1
Unspecified Immune System Problem 1 1
Autoimmune Disorder 1 1
Spinal Column Injury 1 1
Fever 1 1
Paralysis 1 1
Nerve Damage 1 1
Pain 1 1
Unspecified Respiratory Problem 1 1
No Consequences Or Impact To Patient 1 1
Spinal Cord Injury 1 1
Nervous System Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Oct-25-2023
2 Medtronic Sofamor Danek USA Inc II Apr-04-2023
3 Vivorte, Inc. II Jul-07-2021
4 XTANT MEDICAL INC II Mar-19-2020
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