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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Hypoxia (1918)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced probable grade 3 anaphylactic shock due to cement, symptoms included widespread hives, hypotension and desaturation.Medical intervention was required and the patient was transferred to the intensive care unit for monitoring.The patient was discharged from hospital the following day and returned home without complications.On day 1, the patient was able to get out of bed.Postural rehabilitation began.The patient is walking and can sit up easily.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• 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: 25042563
• Report Number: 3015967359-2026-00283
• Device Sequence Number: 9921190
• Product Code: NDN
• UDI-Device Identifier: 07613327170559
• UDI-Public: (01)07613327170559(17)270930(10)VGG030
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: VGG030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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: Required Intervention; Other
• Patient Sex: Unknown