MAUDE Adverse Event Report: STRYKER INSTRUMENTS OMNICURVE; ARTHROSCOPE

Model Number	1032-115-000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the l3 kyphoplasty procedure, the distal portion of the peak sheath from the omnicurve curved needle fractured and became embedded in the cement within the l3 vertebral body.

• Brand Name: OMNICURVE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 25093093
• Report Number: 25093093
• Device Sequence Number: 4968317
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: (01)07613327554496
• 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): 04/27/2026
• Report Date (Section F): 04/27/2026

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
• Device Model Number: 1032-115-000
• Device Catalogue Number: 1032-115-000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/27/2026