MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ROD TI 5.5X480; SPINE ROD

Catalog Number	03.50.403
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department.In a complex case of spinal stabilization (t10-ilieum) undergoing multiple revision surgeries, a bilateral rod breakage has been reported.Pre-revision imaging only shows evidence of breakage in the upper right rod which appears manually bent into a z-shape.The breakage occurred approximately 5 months after the previous surgery (based on the xrays date).Rods often suffer fatigue fractures when fusion does not take place and the device is continuously stressed.In this case, the fracture happened very early, possibly due to the uneven distribution of the load along the construct.For instance, pre-revision x-ray indicates increased kyphosis at the thoracolumbar junction.With the elements at disposal, it is challenging to suspect a defective or malfunctioning device.
Event or Problem Description
Revision surgery due to rod breakage (5.5 x 480 mm ti rod) approximately 6 months after the last surgery.The thoracic part of the primary rods was left in the patient since there were lamina bands attached to it.The surgeon then added a rod from the competitor which has a connector attached to it to the thoracic rod.Additionally, he added the two parallel rods to add more stability.Rods and side-to-side connectors are from competitors.The patient had undergone 3 previous surgeries to extend the construct and 2 previous surgeries due to infection (no medacta devices revised).
Additional Manufacturer Narrative
Items received on 23.May.2024 visual inspection performed by r&d project manager the two rods received were the more caudal of the original construct, that didn't experience any breakage.No defects or anomalies can be detected.The broken part of the device was disposed of by the hospital.No further analysis can be performed with the data provided.

• Brand Name: PEDICLE SCREW ROD TI 5.5X480
• Common Device Name: SPINE ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19330278
• Report Number: 3005180920-2024-00312
• Device Sequence Number: 6910925
• Product Code: KWP
• UDI-Device Identifier: 07630030835360
• UDI-Public: 07630030835360
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 03.50.403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/20/2024
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White