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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that a patient that had been implanted with fibergraft aeridyan had an infection.No additional information was provided.There is no evidence that the infection was due to fibergraft aeridyan, but this complaint is being reported out of an abundance of caution.

• Brand Name: FIBERGRAFT AERIDYAN MATRIX
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• 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: sophia yiantsos ; 41 spring street; suite 107; new providence, NJ 07974
• MDR Report Key: 18565646
• MDR Text Key: 333505991
• Report Number: 3011015097-2024-00002
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other