MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 4.2MM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0909200042
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was undergoing multi-level treatment for a vertebral compression fracture.At l1, the implant on the right side was unable to detach from the expander tube of the expansion kit.After attempts at removal failed, ortho was consulted and the expander tube and working cannula were cut down as close as possible to the bone.As a result, the other level of the procedure was not completed.Total delay in case was approximately 150 minutes.No further adverse consequences were reported.

• Brand Name: SPINEJACK EXPANSION KIT 4.2MM
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 25079954
• Report Number: 3015967359-2026-00293
• Device Sequence Number: 10418857
• Product Code: NDN
• UDI-Device Identifier: 03760253800488
• UDI-Public: (01)03760253800488(17)240831(10)18324-220
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K223294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 0909200042
• Device Lot Number: 18324-220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0406622015 CEMENT, LOT VGF059.; 0909100042 PREP KIT, LOT 18774-10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown