MAUDE Adverse Event Report: BIOMIMETIC THERAPEUTICS, LLC AUGMENT INJECTABLE KIT 1.5CC INJECTABLE USA; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number K30001510

Device Problem Component Missing (2306)

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

Event Date 12/21/2022

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 1.5 cc liquid vial was missing from the kit.Another companies injectable was used to complete the case.

Manufacturer Narrative

The reported event could not be confirmed (packaging - missing product / component) since the device was not returned for evaluation and no other evidences were provided.Quality in arlington examined units from the same lot and determined all components were present.It was also noted that no other complaints have been received for this lot indicating a missing component.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

Event Description

It was reported that the 1.5 cc liquid vial was missing from the kit.Another companies injectable was used to complete the case.

• Brand Name: AUGMENT INJECTABLE KIT 1.5CC INJECTABLE USA
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16194799
• MDR Text Key: 308933789
• Report Number: 3003897776-2023-00001
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 10859477002133
• UDI-Public: 10859477002133
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K30001510
• Device Catalogue Number: K30001510
• Device Lot Number: 1737280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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