MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 13G 5IN MATCH-GROUND BEVEL TIP INTRODUCTION NEEDLE; PERCUTANEOUS CEMENT DELIVERY SYSTEMS

Catalog Number	0306131000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cementoplasty that involved stryker devices that the patient suffered an infection post procedure.It should be noted that there were no issues with any of the devices used.At the time of the procedure there were no patient issues reported.The patient was hospitalized in (b)(6) 2025 with a bacterial infection.We are trying to gather more information of what occurred during that time in the hospital.
Additional Manufacturer Narrative
Upon further information provided, the device did not cause or contribute to the reported infection or post procedure pain.Based on this information, the event is not reportable.
Event or Problem Description
Based on our investigation, the patient was hospitalized due to infectious spondylodiscitis caused by cut bacterium acnes which is not attributed to our device.Additionally, no medical treatment during hospitalization was indicated and the patient experienced pain as a result.Based on this information, this event is not reportable as the device did not cause or contribute to the infection and there is no indication that further medical treatment was required.

• Brand Name: 13G 5IN MATCH-GROUND BEVEL TIP INTRODUCTION NEEDLE
• Common Device Name: PERCUTANEOUS CEMENT DELIVERY SYSTEMS
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 00615 ; * 00615
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 24070027
• Report Number: 3015967359-2026-00029
• Device Sequence Number: 21429068
• Product Code: HRX
• UDI-Device Identifier: 04546540434319
• UDI-Public: (01)04546540434319(17)410315(10)11580515
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0306131000
• Device Lot Number: 11580515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/26/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown