MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SPINEJACK EXPANSION KIT 5.8MM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	0909200058
Medical Device Problem Codes	Use of Device Problem (1670); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bipedicular spinejack procedure at l5 on a patient with myeloma, one side would not expand due to patient anatomy.It was reported that the pathological fracture had blastic and lytic lesions impacting bone quality and strength.After cementing both devices into place, the doctor tamped both access cannulas to ensure cement fill and containment within the vertebral body.During a final lateral x-ray after cement fill and completion of the spinejack procedure, imaging revealed the unexpanded implant had propelled through the anterior wall of the vertebra.The procedure was completed successfully following a 1-hour delay as a vascular surgeon performed an open laparotomy to retrieve the implant.No further medical intervention or adverse consequences have been reported.The patient is doing well.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
D4: full udi unavailable as lot unknown.D9: date of return provided.Follow-up report submitted to document quality investigation results.

• Brand Name: SPINEJACK EXPANSION KIT 5.8MM
• 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: 21786551
• Report Number: 3015967359-2025-00597
• Device Sequence Number: 8692464
• Product Code: NDN
• UDI-Device Identifier: 03760253800495
• UDI-Public: (01)03760253800495
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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 Catalogue Number: 0909200058
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown