MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BENT ROD TI 5.5X75MM; SPINE ROD

Model Number	03.50.458
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-jan-2022: lot 1820271: (b)(4) items manufactured and released on 04-jun-2018.Expiration date: 2023-05-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved: batch review performed on 26-jan-2022: pedicle screw 03.50.458 bent rod ti 5.5x75mm (k121115) lot 1920015: (b)(4) items manufactured and released on12-aug-2019.Expiration date: 2024-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Visual inspection performed by medacta r&d spine project manager: during the visual inspection it has been analyzed: ref.03.50.458 - bent rod ti 5.5x45mm - lot.1820271.Ref.03.50.458 - bent rod ti 5.5x45mm - lot.1920015.The rod are conforming for the dimensional point of view either for the material.A specific analysis of the material has been performed by the control department and the check (see certificate attached) confirmed the material (ti6al4v).The fracture of the rod seems compatible with the application of flextion-extension load.The root cause of the breakage is unclear.
Event or Problem Description
During revision surgery, two must rods were removed and one (pedicle screw 03.50.458, bent rod ti 5.5x75mm, lot 1820271) was discovered to be broken.The primary surgery date is unknown.

• Brand Name: BENT ROD TI 5.5X75MM
• Common Device Name: SPINE ROD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13365947
• Report Number: 3005180920-2022-00051
• Device Sequence Number: 20159545
• Product Code: KWP
• UDI-Device Identifier: 07630030835575
• UDI-Public: 07630030835575
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 01/27/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: 03.50.458
• Device Catalogue Number: 03.50.458
• Device Lot Number: 1820271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• 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: Male