MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VERTAPLEX HV RADIOPAQUE BONE CEMENT - UNIT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0406622015
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Hypoxia (1918); Foreign Body In Patient (2687)
Date of Event	02/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that following the patient underwent percutaneous cemented thoracic arthrodesis for vertebral fractures.Postoperative radiographic examination revealed extracorporeal prevertebral cement leakage at t12 and probable endovenous leakage at l2.The patient was hypotoxic for several days, with no identified cause (pulmonary embolism ruled out).It was further reported that the patient underwent a ct angiogram, which showed the presence of hyperdense material within the pulmonary arteries.It was also reported that there was the presence of cement within the prevertebral venous plexus opposite the t7-t8-t9 and t10 vertebrae.The patient had prolonged hospitalization.And a prescription of curative anticoagulation therapy for 3 months.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
No new information.

• Brand Name: VERTAPLEX HV RADIOPAQUE BONE CEMENT - UNIT
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 24500679
• Report Number: 3015967359-2026-00142
• Device Sequence Number: 9870584
• Product Code: NDN
• UDI-Device Identifier: 07613327170559
• UDI-Public: (01)07613327170559(17)271031(10)VGG024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 0406622015
• Device Lot Number: VGG024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown