XEMPLIFI DBM PLUS
Received Jun 13, 2025 · Event occurred Jun 20, 2024
Report 3000215346-2025-00003 · MDR key 22206972
Device
Generic name
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Manufacturer
AllosourceModel number
8103.0210SLot number
227737-6516
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Bacterial Infection
- Bacterial Infection
Narrative
Description of Event or Problem
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.