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

Catalog Number	0406622015
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Vertebral Fracture (4520)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: udi is unknown as the part/ lot number was not reported.H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that the consistency of the vertaplex bone cement was incorrect and the cement leaked.It was further reported that the patient suffered immediate pain following the operation and later suffered a t8 fracture.The patient underwent a further operation, but did not resolve the pain.It was reported that the patient's pain persists and is considered permanent, and surgical treatment to remove the cement is too high risk to be considered.
Additional Manufacturer Narrative
Additional information d4: product details provided.
Event or Problem Description
No new information.

• Brand Name: VERTAPLEX HV SINGLE PACK
• 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: 22026466
• Report Number: 3015967359-2025-01018
• Device Sequence Number: 7220249
• Product Code: NDN
• UDI-Device Identifier: 07613252254430
• UDI-Public: (01)07613252254430(17)211130(10)VEA036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 11/30/2021
• Device Catalogue Number: 0406622015
• Device Lot Number: VEA036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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