MAUDE Adverse Event Report: XTANT MEDICAL, INC. NANOSS ADVANCED BONE GRAFT SUBSTITUTE; BONE VOID FILLER

Model Number	90-100-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Embolism/Embolus (4438)
Date of Event	06/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the complaint.The device remains in pateint and is not available for investigation.This report will be updated should this information become available at a later date.Batch record review was performed on the associated lot and did not produce any notable findings.A risk line could not be identified because it is unknown what relation the device involved may have had to the reported harm; as a result, it cannot be determined what hazard(s) or sequence of events may have produced the hazardous situation that led to the observed harm.Though infrequent, cardiac arrest is a known complication of spinal surgery.As documented in the ifu for the device system "one of the potential risks identified with any surgical procedure is death".There have been no other complaints of similar nature reported to the manufacturer over the device distribution history.The manufacturer will continue to monitor this product family for complaints from the field.
Event or Problem Description
It was reported that the patient underwent an initial four (4) level anterior cervical discectomy and fusion procedure at c3 to c7 using two anterior interbodies and an anterior plate system and a posterior cervical fixation from c3 to c7 using a competitor posterior interbody and screw system.During the procedure, after the anterior portion of the procedure was completed and during closure of the anterior site, it was noted that the patient coded and was able to be revived.Subsequently, while in the process of flipping the patient from anterior to posterior, approximately 10 minutes after closure of the anterior site, the patient suffered a cardiac arrest and was unable to be revived.It was believed that the patient may have experienced a pulmonary embolus during the flip maneuver.No complications were noted during the anterior portion of the procedure.No further information was available.

• Brand Name: NANOSS ADVANCED BONE GRAFT SUBSTITUTE
• Common Device Name: BONE VOID FILLER
• Manufacturer (Section D): XTANT MEDICAL, INC.; 1800 a north greene st; greenville NC 27834
• Manufacturer (Section G): XTANT MEDICAL, INC.; 1800 north greene street; suite a; greenville NC 27834
• Manufacturer Contact: casey sumlin ; 1800 north greene street; suite a; greenville, NC 27834
• MDR Report Key: 19809795
• Report Number: 3009336436-2024-00001
• Device Sequence Number: 18218385
• Product Code: MQV
• UDI-Device Identifier: 00846468049461
• UDI-Public: 00846468049461
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K141600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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: 11/03/2024
• Device Model Number: 90-100-10
• Device Catalogue Number: 90-100-10
• Device Lot Number: 433928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 27-40 -FSD-14 4.0 X 14MM FSD SCREW; 27-40-FSD-16 4.0 X 16MM FSD SCREW; 27-45-FST-14 4.5 X 14MM FSD SCREW; 27-460 4 LEVEL 60MM PLATE; 27-MODDRILL-12 12MM DRILL BIT; 27-PUSHPIN STAY PIN; 65-C-1517-7-6L 15 X 17 X 7MM 6* SPACER; 65-C-1517-8-6L 15 X17 X 8MM 6* SPACER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 56 YR
• Patient Sex: Male