XEMPLIFI 8103.0001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889095205831), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K071849); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 PATIEN

  Patient problems: Bacterial Infection

  MAUDE report 22206972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071849. One submission often covers many models, so check the product and lot details in each record.

• Z-1562-2014 · Mar 25, 2014 · Terminated
  AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony stru