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

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Event Description

It was reported to the manufacturer on (b)(6) 2023 that a patient from a retrospective clinical study experienced a bone cyst at 12 months requiring surgical intervention.

• 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 st.; suite 107; new providence, NJ 07974
• MDR Report Key: 17988117
• MDR Text Key: 326307724
• Report Number: 3011015097-2023-00016
• 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: Physician
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/23/2023
• 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
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White