MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST MC Ø6X35; SPINE PEDICLE SCREW

Model Number	03.58.443
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 may 2023 lot 2222516: 30 items manufactured and released on 13-jun-2022.Expiration date: 2027-may-24.No anomalies found related to the problem.To date, 26 items of the same lot have been sold with no similar reported event during the period of review.Mysolution planning analysis: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
The patient came in for a post-op appointment and it was observed from x-rays that a screw had become misplaced.At 5 days after the primary surgery, the surgeon redirected the screw, and the surgery was completed successfully.Fluoroscopy was used during the primary.The screw was likely malpositioned during the primary surgery.No issue with the myspine guides occurred during the primary surgery.

• Brand Name: PEDICLE SCREW MUST MC Ø6X35
• 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: 17116003
• Report Number: 3005180920-2023-00416
• Device Sequence Number: 6650189
• Product Code: NKB
• UDI-Device Identifier: 07630971294851
• UDI-Public: 07630971294851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210427
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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 Model Number: 03.58.443
• Device Catalogue Number: 03.58.443
• Device Lot Number: 2222516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2022
• 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: 69 YR
• Patient Sex: Female