MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN

Model Number 03.59.234

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09 february 2022.Lot 2022558: (b)(4).Expiration date: 2026-02-15.No anomalies found related to the problem.(b)(4).Additional implant involved: batch review performed on 09 february 2022.Must lt 03.59.235 must lt 25mm long - pedicle screw ø7x45 cann (k203482) lot 2120686: (b)(4).Expiration date: 2026-05-18.No anomalies found related to the problem.(b)(4).

Event Description

The patient came in for a post-op appointment and it was observed that the must lt pedicle screws had shifted after insertion due to poor bone quality.The surgeon revised the screws with competitor components 2 weeks after primary.The surgery was completed successfully.

• Brand Name: MUST LT 03.59.234 MUST LT 25MM LONG - PEDICLE SCREW Ø7X40 CANN
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13541822
• MDR Text Key: 289894729
• Report Number: 3005180920-2022-00100
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971279605
• UDI-Public: 07630971279605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203482
• 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: 02/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 03.59.234
• Device Catalogue Number: 03.59.234
• Device Lot Number: 2022558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• 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