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

Model Number 03.58.443

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 317118000
• Report Number: 3005180920-2023-00416
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971294851
• UDI-Public: 07630971294851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.58.443
• Device Catalogue Number: 03.58.443
• Device Lot Number: 2222516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female