MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE ATTRAX PUTTY; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	5015010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The attrax putty 10cc unit, (b)(4), was not returned to globus for evaluation however images were supplied that clearly demonstrated migration from the surgical site and the potential infection excipient mixed with the attrax as it was removed from the patient.It is not possible to determine if the unit was directly connected to the observed infection.No new harm event or adverse trend identified with the reported event.Additionally, based on the risk level estimated for this product, this complaint does not justify the need for new or additional risk evaluation.
Event or Problem Description
It was reported that the attrax putty migrated post operatively, the site was also discovered to be infected when the putty was removed.

• Brand Name: NUVASIVE ATTRAX PUTTY
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): NUVASIVE INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22882770
• Report Number: 2031966-2025-00102
• Device Sequence Number: 15668799
• Product Code: MQV
• UDI-Device Identifier: 00887517241566
• UDI-Public: 887517241566
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5015010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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