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

Catalog Number 74000030

Device Problem Insufficient Information (3190)

Patient Problem Purulent Discharge (1812)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported to the manufacturer on november 14, 2023 that there was some drainage from the wound.Based on the provided photo of the wound, there is no indication that the device caused the drainage.A root cause cannot be determined based on the information provided.However, in abundance of caution this event is being reported.

• Brand Name: FIBERGRAFT BG MATRIX
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): PROSIDYAN, INC.; 41 spring st.; suite 107; new providence NJ 07974
• Manufacturer (Section G): PROSIDYAN, INC.; 41 spring st.; suite 107; new providence NJ 07974
• Manufacturer Contact: amanda devine ; 41 spring st.; suite 107; new providence, NJ 07974
• MDR Report Key: 18310226
• MDR Text Key: 330278469
• Report Number: 3011015097-2023-00050
• Device Sequence Number: 1
• Product Code: MQV
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74000030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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