MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP VERTAPLEX SPINE CEMENT TWIN CE; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0406422000
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Extravasation (1842); Hypoxia (1918)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that a patient undergoing percutaneous vertebroplasty (compression fracture of l2 vertebral body type a4 following mva).Cementoplasty with 2 doses of cement per pedicle under scopic control to ensure no leakage.In the icu, the patient desaturated up to 85% immediately post-extubation, requiring niv.Persistent hypoxemia associated with tachycardia prompted angio scanning, which revealed right subsegmental cement pulmonary emboli and bilateral pleuropneumopathy.It was also reported that the patient was admitted to the surgical intensive care unit for niv weaning and then the patient returned to inpatient ward for further management.

• Brand Name: VERTAPLEX SPINE CEMENT TWIN CE
• 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: 20668393
• Report Number: 3015967359-2024-02323
• Device Sequence Number: 18194891
• Product Code: NDN
• UDI-Device Identifier: 37613327141819
• UDI-Public: (01)37613327141819(17)260731(10)VEF030
• 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
• Report Date (Section B): 11/12/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 0406422000
• Device Lot Number: VEF030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: Other; Required Intervention
• Patient Sex: Unknown