MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN

Model Number	03.57.044
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/01/2023
Type of Reportable Event	Death
Event or Problem Description
A medtronic's solera screw was placed on l4/l5 at the primary surgery (we do not know when and where was performed).L5 rt screw seems like already loosened or misplaced.After the removing of the existing screw, the must lt 7mm screw was placed but it was not secured or tightened enough so the surgeon decided to replace with must lt 8mm screw.When the 7mm lt screw was removed, blood bleeding was observed so the surgeon pressed it over and stopped it.Then must lt 8mm screw was placed.Once it was placed and tried to put the setscrew, then the lt screw was backed out.The surgeon decided to remove the 8mm lt screw and left without any screw on l5 rt, then started to close the wound, but realized the bleeding was not stopped yet.The patient was taken to an emergency hospital and died the day after.
Additional Manufacturer Narrative
Batch review performed on 27 mar 2023.Lot 2125491: (b)(4) items manufactured and released on 30-jun-2022.Expiration date: 2027-06-06.No anomalies found related to the problem.To date, no other items of the same lot have been sold.Additional component involved: must lt 03.57.034 must lt 15mm short - pedicle screw ø7x40 cann (k203482) lot 2227031: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-09-14.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.Must lt 03.57.034 must lt 15mm short - pedicle screw ø7x40 cann (k203482) lot.2224926: (b)(4) items manufactured and released on 27-jul-2022.Expiration date: 2027-07-11.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: MUST LT 15MM SHORT - PEDICLE SCREW Ø8X40 CANN
• Common Device Name: 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: 16633976
• Report Number: 3005180920-2023-00212
• Device Sequence Number: 17671546
• Product Code: NKB
• UDI-Device Identifier: 07630971278523
• UDI-Public: 07630971278523
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: 03.57.044
• Device Catalogue Number: 03.57.044
• Device Lot Number: 2125491
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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: Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian