MAUDE Adverse Event Report: PROSIDYAN, INC. FIBERGRAFT BG MATRIX; BONE VOID FILLER

Model Number	FIBERGRAFT BG MATRIX
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, (b)(6) was used in a trauma procedure.The procedure was completed without incident.After the procedure was completed, the company was informed that the product was used past its labelled expiry.Although the product was used past the labelled expiration, the shelf-life for that product was extended on (b)(6) 2018 from eighteen (18) months to twenty-four (24) months.By virtue of this shelf-life extension, the actual product implanted was not "expired", and was in fact within its demonstrated shelf-life, and, as a result, has been assessed not to pose a risk to the patient.Based on post-op follow-up, the surgeon has indicated that the patient is healing well.In an abundance of caution, this incident is being reported.
Event or Problem Description
On (b)(6) 2019, (b)(+) was used in a trauma procedure and implanted in a patient.The procedure was completed without incident.After the procedure was completed, the company was informed that the product was used past its labelled expiry.

• Brand Name: FIBERGRAFT BG MATRIX
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): PROSIDYAN, INC.; 41 spring street; suite 107; new providence NJ 07974
• MDR Report Key: 9379164
• Report Number: 3011015097-2019-00001
• Device Sequence Number: 2387516
• Product Code: MQV
• UDI-Device Identifier: 00856879006151
• UDI-Public: (01)00856879006151(17)190516(10)1711162
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: No Information
• Device Expiration Date: 05/16/2019
• Device Model Number: FIBERGRAFT BG MATRIX
• Device Catalogue Number: 5500-0125
• Device Lot Number: 1711162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other