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

Catalog Number 78000110, 78000060, 76000110

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/03/2023

Event Type  Injury  

Event Description

It was reported to the manufacturer on february 22, 2023 that the product was used in two separate surgeries (b)(6) 2023 where the graft seeped out of the void and into the soft tissues.There were three different devices used in the surgeries.There are no revision surgeries planned at this time.

• Brand Name: FIBERGRAFT BG PUTTY AND FIBERGRAFT BG PUTTY GPS
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• Manufacturer (Section D): PROSIDYAN, INC.; 41 spring street; sutie 107; new providence NJ 07974
• Manufacturer (Section G): PROSIDYAN, INC.; 41 spring street; suite 107; new providence NJ 07974
• Manufacturer Contact: amanda devine ; 41 spring street; suite 107; new providence, NJ 07974 ; 9086175337
• MDR Report Key: 16586389
• MDR Text Key: 311734131
• Report Number: 3011015097-2023-00004
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2023

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
• Device Catalogue Number: 78000110, 78000060, 76000110
• Device Lot Number: 2201054, 2202163, 2201263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/21/2023
• 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