MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE; BONE VOID FILLER

Model Number	90-300-25504
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Our distribution partner surgalign reported the following "possible small dural tear; performed midline incision centered over l3-4; partial laminectomy & did not see further spinal fluid.Placed muscle over defect along with thrombin, gelfoam and tisseel fibrin glue.Pt kept flat for 36hrs then slowly elevate hob.".
Additional Manufacturer Narrative
The device remains in patient and is not available for investigation.A dhr review was performed and the device was manufactured to specifications.This report will be updated should this information become available at a later date.

• Brand Name: NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: casey sumlin ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 15685676
• Report Number: 1833824-2022-00137
• Device Sequence Number: 6497634
• Product Code: MQV
• UDI-Device Identifier: 00846468049546
• UDI-Public: (01)00846468049546(17)231007(10)416804
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2022

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: 10/07/2023
• Device Model Number: 90-300-25504
• Device Catalogue Number: 90-300-25504
• Device Lot Number: 416804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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: Other
• Patient Sex: Unknown