MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM; SPINE PEDICLE SCREW

Model Number	03.50.054
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2023 lot 2020841: (b)(4) items manufactured and released on 18-may-2020.Expiration date: 2025-may-03.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.Other device involved: pedicle screw 03.56.504 must mc cross-connector 27-40mm adjustable (k193365) lot 2227010: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-sep-22.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.
Event or Problem Description
The patient had a primary surgery on (b)(6) 2023, and had a revision surgery on (b)(6) 2023, due to cages migration.On (b)(6) 2023 surgery performed to extend the construct from l3-l5 to l3-s2ai.During the surgery, one screw in l5 was loose and the cross-connector in l5 was found with one hook loose.The cross-connector was removed and replaced with a new one, while the tulip of the screw was blocked, therefore the head adjuster had to be used to remove the screw because the screwdriver cannot be inserted in the head of the screw.The surgery was completed successfully.Delay time was 5min.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: ref.03.50.054 pedicle screw 8x40mm lot.2020841.Tulip is blocked with respect to the screw.The design of tulip for diameter >= 8mm features an opening, to allow assembly of the screw and give a bigger range of motion in one direction, useful for sai trajectory.This design may lead, during final fixation, to locking of the angle.No contraindications are foreseeable for the patient, if this happens.Loosening of the screw may be caused by several factors, such as bone quality, failed osteointegration, etc.Ref.03.56.504 must mc cross-connector 27-40mm adjustable lot.2227010 it was possible to firmly lock the connector in a test block.The potential root cause for the loosening may be the instability of the construct, given by the loosening of the screw.

• Brand Name: PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
• 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: 17144075
• Report Number: 3005180920-2023-00431
• Device Sequence Number: 1907828
• Product Code: NKB
• UDI-Device Identifier: 07630030834417
• UDI-Public: 07630030834417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 05/03/2025
• Device Model Number: 03.50.054
• Device Catalogue Number: 03.50.054
• Device Lot Number: 2020841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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