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

Model Number FIBERGRAFT BG MATRIX

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2019

Event Type  malfunction  

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 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
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): PROSIDYAN, INC.; 41 spring street; suite 107; new providence NJ 07974
• Manufacturer (Section G): PROSIDYAN, INC.; 41 spring street; suite 107; new providence NJ 07974
• Manufacturer Contact: gina nagvajara ; 41 spring street; suite 107; new providence, NJ 07974 ; 9085173666
• MDR Report Key: 9379164
• MDR Text Key: 219393042
• Report Number: 3011015097-2019-00001
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00856879006151
• UDI-Public: (01)00856879006151(17)190516(10)1711162
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• 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
• Patient Outcome(s): Other