MAUDE Adverse Event Report: PROSIDYAN, INC. FIBERGRAFT BG MATRIX, 12.5CC; RESORBABLY CALCIUM SALT BONE VOID FILLER DEVICE

Model Number	5500-0125
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer on (b)(6) 2023 that the product was implanted in the lateral gutters in the patient on a t8-ilium posterior fusion on (b)(6) 2022.On (b)(6) 2022, the patient presented with a severe infection in the posterior lateral gutters.The surgeon remvoed all the product in the posterior lateral gutters and washed out the area.The patient was brought back for wash out two more times, on (b)(6) 2022 and (b)(6) 2022.All the screws, rods, and set screws implanted along with the product on (b)(6) 2022 remained in the patient.

• Brand Name: FIBERGRAFT BG MATRIX, 12.5CC
• Common Device Name: RESORBABLY 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: 16454597
• Report Number: 3011015097-2023-00003
• Device Sequence Number: 12231240
• Product Code: MQV
• UDI-Device Identifier: 00856879006151
• UDI-Public: 00856879006151
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 02/28/2023

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 Model Number: 5500-0125
• Device Catalogue Number: 55000125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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