MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	03.804.701S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that synflate vertebral balloon med was involved in an intraoperative event during a balloon kyphoplasty procedure.The reported failure involved the balloon tearing during inflation, resulting in contrast medium dispersing within the vertebral body, likely due to contact with a bone edge.When attempting to remove the damaged balloon, a portion tore off and remained in situ.This led to a 30-minute surgical delay, required additional x-rays and ct imaging, necessitated an extension of access, and resulted in increased blood loss and a higher risk of infection.

• Brand Name: SYNFLATE
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25160795
• Report Number: 8030965-2026-04557
• Device Sequence Number: 13435599
• Product Code: NDN
• UDI-Device Identifier: 10705034722719
• UDI-Public: (01)10705034722719(17)270601(10)82341378
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: 03.804.701S
• Device Lot Number: 82341378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/02/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 05/25/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female