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

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned.
Event or Problem 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
• Common Device Name: MQV: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BIOGENNIX, LLC; 18007 sky park circle, suite f; irvine CA 92614
• MDR Report Key: 5952979
• Report Number: 3008773560-2016-00001
• Device Sequence Number: 10937162
• Product Code: MQV
• UDI-Device Identifier: 00812593020651
• UDI-Public: 00812593020651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/15/2017
• Device Model Number: N/A
• Device Catalogue Number: 012-MOR
• Device Lot Number: 10657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other