MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. POLYAXIAL PEDICLE SCREW; PEDICLE SCREW 10X45MM + NUT (1X) - STERILE

Model Number	03.50.093
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22 april 2025.Lot 2225641: (b)(4) items manufactured and released on 31-aug-2022.Expiration date: 2027-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Visual inspection performed by r&d project manager.The setscrew is not present.The tulip thread is damaged; it was not possible engaging a new setscrew.Root cause could be the cross threading during the surgery.It is likely that setscrew has been inserted without guiding of a reduction instrument.If this happens, the risk of misalignment between tulip and setscrew is higher and can lead to cross threading.
Event or Problem Description
Spinal fixation was performed at l3-sai.After insertion of the rod, final tightening was performed, but the right side of l5 could not be torqued properly.An ominous noise led the surgeon to conclude that cross-threading had occurred and replaced the set screw, then reinserted the set screw, but cross-threaded occured again.The surgeon concluded that the pedicle screw head threads were faulty and replaced it with a new screw (lot:2229775), completing the surgery.Due to this event the surgery was prolonged about 1 hour and 30 minutes.The delay was due to multiple attempts to insert the set screw ,and the surgeon once removed the rod and then replace the new pedicle screw.

• Brand Name: M.U.S.T. POLYAXIAL PEDICLE SCREW
• Common Device Name: PEDICLE SCREW 10X45MM + NUT (1X) - STERILE
• 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: 22051616
• Report Number: 3005180920-2025-00448
• Device Sequence Number: 15680682
• Product Code: KWQ
• UDI-Device Identifier: 07630030834721
• UDI-Public: 07630030834721
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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: 03.50.093
• Device Lot Number: 2225641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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 Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian