MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN; SPINE PEDICLE SCREW

Catalog Number	03.59.225
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment and it was observed that a set screw had popped out.About 2 weeks after the primary surgery, the surgeon locked down the rod and put in a new set screw.The surgery was completed successfully.Torque limiter used.
Additional Manufacturer Narrative
It is unknown which is the screw involved in the event batch review performed on 17 january 2024: pedicle screw 03.59.225 must lt 25mm long - pedicle screw ø6x45 cann (k203482) lot.2126530 lot 2126530: (b)(4) items manufactured and released on 01-jul-2022.Expiration date: 2027-jun-06.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 03.59.225 must lt 25mm long - pedicle screw ø6x45 cann (k203482) lot.2221953 lot 2221953: (b)(4) items manufactured and released on 26-jul-2022.Expiration date: 2027-jun-30.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 03.59.225 must lt 25mm long - pedicle screw ø6x45 cann (k203482) lot.2225791 lot 2225791: (b)(4) items manufactured and released on 10-aug-2022.Expiration date: 2027-jul-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 03.59.225 must lt 25mm long - pedicle screw ø6x45 cann (k203482) lot.2228147 lot 2228147: (b)(4) items manufactured and released on 15-nov-2022.Expiration date: 2027-oct-23.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 03.59.235 must lt 25mm long - pedicle screw ø7x45 cann (k203482) lot.2225796 lot 2225796: (b)(4) items manufactured and released on 12-oct-2022.Expiration date: 2027-sep-06.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 03.59.235 must lt 25mm long - pedicle screw ø7x45 cann (k203482) lot.2228148 lot 2228148: (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 2027-oct-20.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.

• Brand Name: MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN
• 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: 18543707
• Report Number: 3005180920-2024-00004
• Device Sequence Number: 8926176
• Product Code: NKB
• UDI-Device Identifier: 07630971279544
• UDI-Public: 07630971279544
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 01/19/2024

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: 03.59.225
• Device Lot Number: 2126530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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