MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN

Model Number	03.59.225
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 july 2021, lot 2022553: 70 items manufactured and released on 01-march-2021.Expiration date: 2026-02-15.No anomalies found related to the problem.To date, 4 items of the same lot have been sold without any similar reported event.Additional implant involved: must lt 03.59.235 must lt 25mm long - pedicle screw ø7x45 cann (k203482) lot.2022559, batch review performed on 05 july 2021.Lot 2022559: 57 items manufactured and released on 01-march-2021.Expiration date: 2026-02-16.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with a similar event reported on this lot.Note that two equal devices have been reported in this case.Clinical evaluation performed by medical affairs director a patient of bi-level lumbar fixation complains about pain few weeks after surgery.The screws on the left side were removed and not replaced.The cause of pain is unknown, but there is no reason to suspect a faulty device.
Event or Problem Description
1 month after the primary, the patient came in reporting pain on the left side and the cause of the pain is unknown.The surgeon removed three screws from the patient's left side and did not implant anything to replace them.The surgery was completed successfully.

• Brand Name: MUST LT MUST LT 25MM LONG - PEDICLE SCREW 6X45 CANN
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12127997
• Report Number: 3005180920-2021-00546
• Device Sequence Number: 4424358
• Product Code: NKB
• UDI-Device Identifier: 07630971279544
• UDI-Public: 07630971279544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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 Expiration Date: 02/15/2026
• Device Model Number: 03.59.225
• Device Catalogue Number: 03.59.225
• Device Lot Number: 2022553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention