MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW PEDICLE SCREW 5X40; SPINE PEDICLE SCREW

Catalog Number	03.50.011
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years 2 months after the primary, the patient came in reporting pain.The surgeon revised the m.U.S.T screws in the original construct at l2 - l4, with m.U.S.T.Mc screws and extended the construct to now include l4 - l5.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 january 2024.Lot 157323: (b)(4) items manufactured and released on 13-jan-2016.Expiration date: 2020-12-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional implants involved.Batch review performed on 17 january 2024 on pedicle screw 03.50.011 pedicle screw 5x40 (k121115) lot.1923854.Lot 1923854: (b)(4) items manufactured and released on 04-feb-2020.Expiration date: 2025-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with three other similar reported events during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.011 pedicle screw 5x40 (k121115) lot.2020325 lot 2020325: (b)(4) items manufactured and released on 24-march-2020.Expiration date: 2025-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.013 pedicle screw 5x50 (k121115) lot.2020328.Lot 2020328: (b)(4) items manufactured and released on 29-apr-2020.Expiration date: 2025-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.018 pedicle screw 6x45 (k121115) lot.1820659.Lot 1820659: (b)(4) items manufactured and released on 28-sep-2018.Expiration date: 2023-09-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.018 pedicle screw 6x45 (k121115) lot.1821273.Lot 1821273: (b)(4) items manufactured and released on 04-jan-2019.Expiration date: 2023-12-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.018 pedicle screw 6x45 (k121115) lot.1923861.Lot 1923861: (b)(4) items manufactured and released on 25-feb-2020.Expiration date: 2025-02-09.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.457 bent rod ti 5.5x70mm (k121115) lot.2020532.Lot 2020532: (b)(4) items manufactured and released on 03-july-2020.Expiration date: 2025-06-18.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 january 2024 on pedicle screw 03.50.458 bent rod ti 5.5x75mm (k121115) lot.1821904.Lot 1821904: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-03-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: PEDICLE SCREW PEDICLE SCREW 5X40
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18524978
• Report Number: 3005180920-2023-01109
• Device Sequence Number: 7900997
• Product Code: KWP
• UDI-Device Identifier: 07630030834141
• UDI-Public: 07630030834141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 01/17/2024

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: 12/02/2020
• Device Catalogue Number: 03.50.011
• Device Lot Number: 157323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2016
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White