MAUDE Adverse Event Report: PROSIDYAN, INC. FIBERGRAFT BG PUTTY, 11CC; RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE

Model Number 78000110

Device Problem Insufficient Information (3190)

Patient Problem Implant Pain (4561)

Event Date 01/13/2023

Event Type  Injury  

Event Description

It was reported to the manufacturer on (b)(6) 2023 that a patient complained they could feel something hard under the skin.Additional information was provided on january 30, 2023 indicating that secondary surgery was performed to explore and remove the product from the soft tissue.The surgeon also stated that the patient had a palpable, painful mass that correlated with the product in the soft tissue on the lateral calcaneus.Based on the information provided by the surgeon, it was determined that this event should be reported.

• Brand Name: FIBERGRAFT BG PUTTY, 11CC
• 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: amanda devine ; 41 spring street; suite 107; new providence, NJ 07974 ; 9086175337
• MDR Report Key: 16341499
• MDR Text Key: 309207664
• Report Number: 3011015097-2023-00001
• Device Sequence Number: 1
• Product Code: MQV
• UDI-Device Identifier: 00856879006731
• UDI-Public: (01)00856879006731
• 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: 02/09/2023

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 Model Number: 78000110
• Device Catalogue Number: 78000110
• Device Lot Number: 2109011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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): Required Intervention