MAUDE Adverse Event Report: BIOGENNIX, LLC OSTEOSPAN MORPHEUS; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned.

Event Description

A hospital representative verbally contacted a biogennix distributor requesting product testing and sterilization information on three different morpheus lots.The hospital was performing a follow-up investigation on three separate patient infections that occurred over a period of several weeks following surgical procedures in which morpheus was used concomitantly with other undisclosed devices.Biogennix assessment: dhr review confirmed that morpheus was provided sterile and is unlikely to cause a contamination or infection.Since the product was not returned and additional product samples from this lot are no longer available, we cannot conduct any further investigation.All units from this lot have been implanted and no other adverse reports have been received.If additional information is obtained that adds value to the relevant content of this report and/or conclusion can be drawn, a follow-up report will be submitted.

• Brand Name: OSTEOSPAN MORPHEUS
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BIOGENNIX, LLC; 18007 sky park circle, suite f; irvine CA 92614
• Manufacturer (Section G): BIOGENNIX, LLC; 18007 sky park circle, suite f; irvine CA 92614
• Manufacturer Contact: miguel lira ; 18007 sky park circle, suite f; irvine, CA 92614 ; 9492530994
• MDR Report Key: 5953021
• MDR Text Key: 54820659
• Report Number: 3008773560-2016-00002
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00812593020651
• UDI-Public: 00812593020651
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2017
• Device Model Number: N/A
• Device Catalogue Number: 012-MOR
• Device Lot Number: 10711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other