MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 8X35; SPINE SACRO ILIAC SCREW J

Model Number	03.65.503
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department: the object of this report, in lour understanding, is the necessity to remove 3 iliac screws three years after lumbo-sacral-iliac stabilization because of pain.There is no hint that such pain could have been caused by defective devices.
Event or Problem Description
Revision surgery after about 3 years due to pain, the surgeon wanted to remove the 3 iliac screws in order to solve the pain issue.
Additional Manufacturer Narrative
Additional information added: batch review performed on 19 april 2023: lot 1821608: (b)(4) items manufactured and released on 15-feb-2019.Expiration date: 2024-02-03.No anomalies found related to the problem.To date, 15 items of the same lot have been sold without any similar reported event in the period of review.Details of the joint screw (reference, lot, manufacturer and expiration date, pma/510 (k) number, udi number, batch analysis).Corrected data: description updated by adding: during the screw removal the 3 screws broke.
Event or Problem Description
Revision surgery after about 3 years due to pain, the surgeon wanted to remove the 3 iliac screws in order to solve the pain issue.During the screw removal the 3 screws broke.

• Brand Name: SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 8X35
• Common Device Name: SPINE SACRO ILIAC SCREW J
• 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: 16732222
• Report Number: 3005180920-2023-00260
• Device Sequence Number: 12437525
• Product Code: OUR
• UDI-Device Identifier: 07630030880834
• UDI-Public: 07630030880834
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 02/03/2024
• Device Model Number: 03.65.503
• Device Catalogue Number: 03.65.503
• Device Lot Number: 1821608
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2019
• 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: Female