MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREWS SYSTEM; MUST POLYAXIAL CANN SCREW Ø7X40 - Ø5.5/6

Model Number	03.68.391
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 29-10-2025.Pedicle screw 03.68.391 must polyaxial cann screw d 7x40 - d 5.5/6 (k234048) lot 2458063: (b)(4) items manufactured and released on 03-apr-2024 expiration date: 2029-03-07.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.Pedicle screw 03.68.392 must polyaxial cann screw d 7x45 - d 5.5/6 (k234048) lot 2458064: (b)(4) items manufactured and released on 02-apr-2024 expiration date: 2029-03-06.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.Pedicle screw 03.68.393 must polyaxial cann screw d 7x50 - d 5.5/6 (k234048) lot 2329189: (b)(4) items manufactured and released on 07-mar-2024 expiration date: 2029-02-13.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.Pedicle screw 03.68.393 must polyaxial cann screw d 7x50 - d 5.5/6 (k234048) lot 2464193: (b)(4) items manufactured and released on 19-nov-2024 expiration date: 2029-11-04.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.It should be noted that 6 screws are listed in this complaint from 4 different lots, it is unknown which screw presents the unscrewing clinical evaluation performed by clinical affairs department: after a spine fusion surgery from l3 to l5, the patient came for a routine follow-up x-ray, which revealed a dislocation of a set screw from the corresponding tulip screw.The patient did not report any symptoms.The available imaging confirms the dislocation of the set screw from one of the two most proximal tulip screws.Determining the cause of this failure is challenging based on the available information.The most likely hypothesis could be an issue during the locking maneuver, although this remains uncertain.However, considering that the set screw is now freely located within the soft tissues, we cannot exclude the possibility of secondary migration.Moreover, the overall construct has a reduced mechanical strength, as one of the rod has lost its proximal anchorage.For these reasons, potential secondary complications cannot be excluded.Root cause:based on the information available it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
Patient underwent spine fixation surgery (l3-l5) on the (b)(6) 2025.Post-op follow-up xray showed dislocation of a set screw from the construct.Althougth the provided xray may suggest that the involved screw is a ø7x50 one, it cannot be confirmed from which screw the setscrew detached.Patient does not report any pain and currently no revision surgery is planned.
Additional Manufacturer Narrative
Torque limiter handles verification: three torque limiter handles were received (used for set screws fixation) and subjected to torque verification testing.The results of the analysis did not reveal any evidence of insufficient torque application.Based on these findings, the reported set screw loosening cannot be attributed to inadequate torque delivery by the torque limiter handles.Root cause: no action can be planned at this time as no root cause could be identified with the information available, while the event has been included in our active monitoring system for potential capa needs and opportunities.

• Brand Name: M.U.S.T. PEDICLE SCREWS SYSTEM
• Common Device Name: MUST POLYAXIAL CANN SCREW Ø7X40 - Ø5.5/6
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23510654
• Report Number: 3005180920-2025-01101
• Device Sequence Number: 9770179
• Product Code: NKB
• UDI-Device Identifier: 07630542704598
• UDI-Public: 07630542704598
• Combination Product (Y/N): N
• PMA/510(K) Number: K234048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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 Model Number: 03.68.391
• Device Lot Number: 2458063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2024
• 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 Sex: Unknown