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

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported to the manufacturer on september 25, 2023 that a patient from a retrospective clinical study experienced infection, tenderness, hematoma, swelling requiring antibiotics at 1 month.At 6 months the patient experienced another infection requiring i&d and antibiotic spacer placement.At 12 months the patient required implant revision.

• Brand Name: FIBERGRAFT BG 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: 17988289
• MDR Text Key: 326309382
• Report Number: 3011015097-2023-00033
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• 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): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White