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

Model Number K30003010

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the package had a 1.5cc vial instead of the 3cc vial.The product was difficult to mix because of the ration of liquid to bbtcp.The surgeon was able to inject at the site with no patient complications reported.There was no backup kit available.No impact to patient, just less product used than planned.No delay.

• 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: 11886004
• MDR Text Key: 252705374
• Report Number: 3003897776-2021-00002
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 04/28/2021
• 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