MAUDE Adverse Event Report: BIOMIMETIC THERAPEUTICS, LLC AUGMENT INJECTABLE; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number	K30003010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Diabetic neuropathic charcot patient underwent ttc fusionas a limb salvage procedure using non-syk ttc nail system.Surgeon reports utilizing augment inj & vivigen bellular allograft in index procedure.At approximately 3 months post-implantation, radiographic imaging indicated evidence of inadequate bone formation in treated joints, further deterioration of overall hindfoot bone stock (charcot-marie tooth disease) and loosening of screw in ttc nail, and a revision surgery was scheduled.Revision surgery was performed as scheduled on (b)(6) 2021 during which ignite and infuse bone graft were implanted, and the loosed screw was removed and replaced.No other adverse impacts to the patient were reported.

• Brand Name: AUGMENT INJECTABLE
• Common Device Name: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• MDR Report Key: 12406704
• Report Number: 3003897776-2021-00003
• Device Sequence Number: 5003083
• Product Code: NOX
• UDI-Device Identifier: 10859477002140
• UDI-Public: 10859477002140
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: K30003010
• Device Catalogue Number: K30003010
• Device Lot Number: 1706343
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention