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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, synthetic peptide
Definition The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
Product CodeNOX
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 3 5 0 2 5 1 1 4 3 0

MDR Year MDR Reports MDR Events
2016 1 1
2019 1 1
2020 1 1
2021 7 7
2022 2 2
2023 1 1
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 11 11
Manufacturing, Packaging or Shipping Problem 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Clumping in Device or Device Ingredient 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Seroma 3 3
Pain 3 3
Failure of Implant 2 2
Neck Pain 2 2
Inadequate Osseointegration 1 1
Malunion of Bone 1 1
Implant Pain 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Nerve Damage 1 1
Local Reaction 1 1
Joint Disorder 1 1
Ossification 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioMimetic Therapeutics, LLC II Aug-23-2021
2 Cerapedics, Inc. III May-10-2022
3 Theken Spine Llc II Nov-01-2010
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