MAUDE Adverse Event Report: STRYKER CORPORATION; SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY

Model Number	0306621000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We were performing a multiple level kyphoplasty on the patient.We were working on the l1 vertebrae and after access was gained using the 11g access needle, the 11g curette was introduced.The 11g curette is used to displace sclerotic/cancellous bone during percutaneous balloon-assisted vertebral augmentation procedures.The curette was inserted, and the physician was tapping the device to displace the sclerotic bone when the curette became lodged in the bone.The device was then twisted to try and displace the bone when the tip of the device sheared off and the distal portion of the curette broke off, leaving a piece of the device in the vertebral body.The tip off the curette was wedged to far within the bone and no attempt to retrieve it was made.The decision was made to leave the foreign body in place and fill the vertebral body with cement.The stryker rep [representative] was present and discovered the parts of the metal are made of nitinol and many of the implants used today are made of this material.

• Brand Name: NA
• Common Device Name: SPINAL CHANNELING INSTRUMENT, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 23004049
• Report Number: 23004049
• Device Sequence Number: 9469214
• Product Code: OCJ
• UDI-Device Identifier: 07613252639794
• UDI-Public: (01)07613252639794(17)280203(10)10435915
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2025
• Report Date (Section F): 08/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0306621000
• Device Catalogue Number: 0306-621-000
• Device Lot Number: 10435915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/20/2025