MAUDE Adverse Event Report: PROSIDYAN, INC. FIBERGRAFT; BONE GRAFT SUBSTITUTE

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

Information was provided to the manufacturer indicating that the graft was used in long constructs for recon of spine for a few patients.Patients experienced serious collection.Per the complaint description received, there are other potential concurrent factors for the serous collection in these patients, but use of the product was stopped as a precaution.

• Brand Name: FIBERGRAFT
• Type of Device: BONE GRAFT SUBSTITUTE
• 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: 18479694
• MDR Text Key: 332491294
• Report Number: 3011015097-2024-00001
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2024

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: Not provided
• Initial Date FDA Received: 01/09/2024
• 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