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

Catalog Number 03.59.225

Device Problem Migration (4003)

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

Event Date 01/02/2024

Event Type  Injury  

Event 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.

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
• 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: 18543707
• MDR Text Key: 333253553
• Report Number: 3005180920-2024-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971279544
• UDI-Public: 07630971279544
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.59.225
• Device Lot Number: 2126530
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2022
• 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