MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW SYSTEM; PEDICLE SCREW FENESTRATED POLYAXIAL CANNULATED PEDICLE SCREW 6X45,DUAL

Model Number	03.61.324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed about 4 months after the primary surgery due to s1 screws breakage.6.0x45mm screw broke at the tip, while 7.0x40mm screw broke at the head/tulip.Patient with good quality bone, heavy patient (around 90kg).No trauma reported.
Additional Manufacturer Narrative
Batch review performed on 28 may 2025.Lot 2460237: (b)(4) items manufactured and released on 25/06/2024.Expiration date: 04/06/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional device involved: batch review performed on 28 may 2025 pedicle screw 03.61.337 fenestrated polyaxial cannulated pedicle screw 7x40, dual-diameter (k241034) lot 2223029: (b)(4) items manufactured and released on 17/05/2022.Expiration date: 28/04/2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by medacta spine r&d project manager: the tip of 6.0x45mm screw is not broken.Both screws show a breakage at the head level and signs of gripping on the threaded part, likely due to screw removal maneuver.Possible root cause of the breakage could be the weigth of the patient and lack of osteointegration.No x-ray images have been received.
Event or Problem Description
Modified event description: revision surgery performed about 4 months after the primary surgery due to s1 screws breakage (below the head).Patient with good quality bone, heavy patient (around 90kg).No trauma reported.
Additional Manufacturer Narrative
New event description revision surgery performed about 4 months after the primary surgery due to s1 screws breakage (below the head).Patient with good quality bone, heavy patient (around 90kg).No trauma reported.Visual inspection performed by medacta spine r&d project manager: both screws show a breakage below the head.Additionally, signs of gripping on the threaded part can be noted, but are likely due to screw removal maneuver.Although sufficient information is not available to determine a definitive root cause, the breakage was likely due to material fatigue.This may be generated by missing or delayed fusion that stressed the construct, along with the patient's specific contributing factor (weight and bone quality).Root cause: the screw breakages were most likely due to insufficient bone fusion, in combination with the patient's high bone density and body weight, which likely resulted in excessive mechanical loading on the implants.While the exact root cause cannot be definitively confirmed, the investigation found no evidence of manufacturing defects or systemic issues related to the device.

• Brand Name: M.U.S.T. PEDICLE SCREW SYSTEM
• Common Device Name: PEDICLE SCREW FENESTRATED POLYAXIAL CANNULATED PEDICLE SCREW 6X45,DUAL
• 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: 22327510
• Report Number: 3005180920-2025-00553
• Device Sequence Number: 8429751
• Product Code: PML
• UDI-Device Identifier: 07630030862120
• UDI-Public: 07630030862120
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K241034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 03.61.324
• Device Lot Number: 2460237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Hispanic
• Patient Race: White