MAUDE Adverse Event Report: RTI SURGICAL, INC NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE; BONE VOID FILLER, PRODUCT CODE: MQV

Model Number 90-300-25504

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

The device remains in patient and is not available for investigation.This report will be updated should this information become available at a later date.

Event Description

On 06/02/2023 rti surgical was informed of the following by surgalign: "part number: nanoss 3d 90-300-25504, streamline tl screws 01-pa-65-50 x 4, 01-pa-65-45 x 2, 01-setscrew x6, streamline tl rods 10-55-pr-80 x2.Batch number: none provided.Surgical technique: alif.Xrays/pictures: none.Patient recover: original surgery was l4-5, l5-s1 on (b)(6)2022.Intervention occurred (b)(6)2022 to redo the foraminotomy bilaterally at l4-5 and on the left at l5-s1.Patient is now 6 months post revision and reports: he is doing much better and feels like things have improved, only complaint is about numbness in his left foot.Off all pain medications and is not taking anything related to his back".

• Brand Name: NANOSS 3D ADVANCED BONE GRAFT SUBSTITUTE
• Type of Device: BONE VOID FILLER, PRODUCT CODE: MQV
• Manufacturer (Section D): RTI SURGICAL, INC; 1800 a n greene st; greenville NC 27834
• Manufacturer (Section G): RTI SURGICAL, INC.; 1800 a n greene st.; greenville NC 27834
• Manufacturer Contact: casey sumlin ; 1800 a n greene st; greenville, NC 27834 ; 2523538200
• MDR Report Key: 17201744
• MDR Text Key: 317989766
• Report Number: 1833824-2023-00045
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 90-300-25504
• Device Catalogue Number: 90-300-25504
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• 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): Other