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

Model Number	78000110
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3011015097-2023-00001
• Device Sequence Number: 6873753
• Product Code: MQV
• UDI-Device Identifier: 00856879006731
• UDI-Public: (01)00856879006731
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown