MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 7X45; SPINE PEDICLE SCREW

Model Number	03.50.031
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
About 1 year and 6 months after the primary surgery, a revision surgery was performed due to l3/4/5 screws loosening and l4/5 not fusion.It is unknown which screw came loose.The l3-5 screw was removed to replace the cage.
Additional Manufacturer Narrative
Batch review performed on 6 sep 2022.Lot 2022278: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-sep-23.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 (2 items reported in this complaint).Additional implanted components.Batch review performed on 6 sep 2022 on pedicle screw 03.50.031 pedicle screw 7x45 (k121115) lot 1923134: (b)(4) items manufactured and released on 29-oct-2019.Expiration date: 2024-oct-01.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.Batch review performed on 6 sep 2022 on pedicle screw 03.50.031 pedicle screw 7x45 (k121115) lot 2021798: (b)(4) items manufactured and released on 30-jul-2020.Expiration date: 2025-jul-16.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.Batch review performed on 6 sep 2022 on pedicle screw 03.50.031 pedicle screw 7x45 (k121115) lot 2022667: (b)(4) items manufactured and released on 22-oct-2020.Expiration date: 2025-oct-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 (2 items reported in this complaint).
Additional Manufacturer Narrative
Date of manufacturer alerted corrected with 8 august 2022.The initial emdr results to be sent with 1 day of delay because the awareness date reported was not correct.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 7X45
• Common Device Name: SPINE PEDICLE SCREW
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15390881
• Report Number: 3005180920-2022-00680
• Device Sequence Number: 5057021
• Product Code: KWP
• UDI-Device Identifier: 07630030834295
• UDI-Public: 07630030834295
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 10/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2025
• Device Model Number: 03.50.031
• Device Catalogue Number: 03.50.031
• Device Lot Number: 2022278
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2020
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian