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	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.D4: full udi number will be provided with the follow-up report.
Event or Problem Description
It was reported that during the procedure the doctor was having a difficult time removing the avaflex device which lead to the handle snapping off.The avaflex was cut just under the skin and implanted with cement.Per the doctor the patient will need a revision surgery.The procedure was completed successfully.
Additional Manufacturer Narrative
D4: full udi provided.H6: the quality investigation is complete.
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: 20622996
• Report Number: 3015967359-2024-02309
• Device Sequence Number: 12988163
• Product Code: NDN
• UDI-Device Identifier: 07613327170559
• UDI-Public: (01)07613327170559(17)250831(10)VIE080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 0406622015
• Device Lot Number: VIE080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 05/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATALOG#: 1025011000, LOT#: 9545146.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown