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

Device Problem Insufficient Information (3190)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

After a review of the journal article by medical affairs, (vicenti, g., et.Al., (2022), use of the 95-degree angled blade plate with biological and mechanical augmentation to treat proximal femur non-unions: a case series, bmc musculoskeletal disorders, vol.22 (xx) pages 1-11, (italy)), it was reported to the manufacturer on march 12, 2024 that one of the fifteen patients had wound dehiscence, which was treated with a superficial surgical debridement.It was stated in the study that the product was used in two of the fifteen patients.It was not confirmed whether the patient that experienced the wound dehiscence was one of the patients that received the product so it is unknown if the product was involved, but the complaint is being reported out of an abundance of caution.

• Brand Name: FIBERGRAFT BG PUTTY
• Type of Device: RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE
• 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 street; suite 107; new providence, NJ 07974
• MDR Report Key: 19087026
• MDR Text Key: 339898766
• Report Number: 3011015097-2024-00004
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male