MAUDE Adverse Event Report: ALLOSOURCE XEMPLIFI DBM PLUS; FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)

Model Number	8103.0210S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On may 22nd, 2025, the regulatory affairs department received notification of a potential adverse event submitted by najia uddin of globus medical on behalf of medstar union memorial hospital in baltimore maryland, regarding a potential post-op infection of coag negative staphylococcus & mssa in a patient who received our xemplifi dbm plus 10cc device, lot number id# 227737-6516, for a surgical procedure performed on (b)(6) 2024.Additional information has been requested from (b)(6), through the medical adverse occurrence questionnaire and an investigation of the processing records, donor records, and environmental data will be initiated.Description: as reported from (b)(6): this email is to notify you of a complaint currently being investigated for xemplifi dbm.See attached for documents detailing the event.Please provide us with the investigation report for this complaint as soon as possible in order for us to write a close-out letter and provide it to the hospital.Surgeon: dr.(b)(6), m.D.Facility & location: (b)(6) hospital.(b)(6).And (b)(6).Products: globus - xemplifi dbm plus 10cc device.Part number 83338010eu.Donor/lot: 227737-6516.Preliminary information: a patient who developed a post-op infection of coag negative staphylococcus & mssa on (b)(6) 2024.
Additional Manufacturer Narrative
(b)(4) lots produced from donor (b)(6) were distributed from allosource.No other adverse events or complaint have been reported.

• Brand Name: XEMPLIFI DBM PLUS
• Common Device Name: FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
• Manufacturer (Section D): ALLOSOURCE; 6278 s troy circle; centennial CO 80111
• Manufacturer (Section G): ALLOSOURCE; 6278 s troy circle; centennial CO 80111
• Manufacturer Contact: bilal karaze ; 6278 s troy circle; centennial, CO 80111
• MDR Report Key: 22206972
• Report Number: 3000215346-2025-00003
• Device Sequence Number: 8148794
• Product Code: MBP
• UDI-Device Identifier: 00889095205831
• UDI-Public: (01)00889095205831(17)250428(10)2277376516
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Model Number: 8103.0210S
• Device Lot Number: 227737-6516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2023
• 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