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

Model Number K30003010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inadequate Osseointegration (2646)

Event Date 08/05/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Event 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
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• Manufacturer (Section G): BIOMIMETIC THERAPEUTICS, LLC; 389 nichol mill lane; franklin TN 37067
• Manufacturer Contact: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12406704
• MDR Text Key: 269340659
• Report Number: 3003897776-2021-00003
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 10859477002140
• UDI-Public: 10859477002140
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention