MAUDE Adverse Event Report: HANS BIOMED VIVEX DBM PLUS; BONE VIOD FILLER

Model Number	VX-EP5
Health Effect - Clinical Codes	Fever (1858); Nausea (1970); Pain (1994); Swelling (2091); Loss of consciousness (2418)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient complained of swelling and pain in her leg.Patient was home when she felt nausea feverish and passed out at home.Surgeon looked at her immediately, same day surgery; drainage, treated for post-op infection, graft was not removed; incision made arthroscopic; gram scan; biopsy performed.Patient is now healing in rehab.

• Brand Name: VIVEX DBM PLUS
• Common Device Name: BONE VIOD FILLER
• Manufacturer (Section D): HANS BIOMED; 64, yuseong-daero 1628beon-gil; yuseong-gu; daejeon, 34054 ; KS 34054
• MDR Report Key: 7262330
• Report Number: 3003828812-2018-00001
• Device Sequence Number: 16623729
• Product Code: MQV
• UDI-Device Identifier: 08809204339235
• UDI-Public: (01)08809204339235(17)180118(01)08809204339235(17)180118(21)Q16010U-058
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K113728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Expiration Date: 01/18/2018
• Device Model Number: VX-EP5
• Device Lot Number: Q16011U
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 72