MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED; SPINE SCREW CANNULATED

Catalog Number	03.58.225
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2023 lot 2225728: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-18.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.Only one screw was involved but it is unknown which one.Here below all the screws implanted during the primary: pedicle screw 03.58.244 must mc screw ø6x40 cannulated (k210427) lot 2229875: (b)(4) items manufactured and released on 08-feb-2023.Expiration date: 2028-01-19.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.Pedicle screw 03.58.245 must mc screw ø6x45 cannulated (k210427) lot 2222501: (b)(4) items manufactured and released on 22-jun-2022.Expiration date: 2027-05-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other similar reported event during the period of review.Two devices involved in this event.Pedicle screw 03.58.243 must mc screw ø6x35 cannulated (k210427) lot 2222176: (b)(4) items manufactured and released on 13-jun-2022.Expiration date: 2027-05-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with other similar reported event during the period of review.Two devices involved in this event.
Event or Problem Description
At about 3 months from the primary, the patient came in for a post-op appointment and one of the six screws was observed to be broken at the bottom of the construct.It is unknown how/why this occurred.A revision surgery has not been scheduled yet.

• Brand Name: PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED
• Common Device Name: SPINE SCREW CANNULATED
• 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: 18191999
• Report Number: 3005180920-2023-00915
• Device Sequence Number: 12574463
• Product Code: NKB
• UDI-Device Identifier: 07630971293373
• UDI-Public: 07630971293373
• 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
• 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): 11/22/2023

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 Catalogue Number: 03.58.225
• Device Lot Number: 2225728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2022
• 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 Sex: Unknown