InjuryMBB

TOBRA FULL DOSE ANTIBIOTIC BONE CEMENT, 10 PACK

Received Jun 13, 2025 · Event occurred Jul 4, 2023

Report MW5171473 · MDR key 22204939

Device

Generic name

Bone Cement, Antibiotic

Manufacturer

Howmedica Osteonics Corp.

Catalog number

6197- 9-010

Lot number

MEU049

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

Bone Fracture(s)
Bone Fracture(s)

Narrative

Description of Event or Problem

SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR L SHOULDER FRACTURE. DEVICE AND PROCEDURE (RELATEDNESS). RELATION TO STUDY DEVICE? NO INFORMATION PROVIDED. RELATION TO STUDY PROCEDURE? NO INFORMATION PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).