MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN; SPINE PEDICLE SCREW

Model Number 03.57.035

Device Problem Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 10/06/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 11-nov-2022: lot 2222997: (b)(4) items manufactured and released on 13-jul-2022.Expiration date: 2027-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: batch review performed on 11-nov-2022: must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2222427: (b)(4) items manufactured and released on 07-jul-2022.Expiration date: 2027-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2220332: (b)(4) items manufactured and released on 20-apr-2022.Expiration date: 2027-02-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2221910: (b)(4) items manufactured and released on 19-may-2022.Expiration date: 2027-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

At about 1 month after the primary surgery, a revision surgery was performed because 4 of the 6 reported screws backed out.Moreover, during the revision a screw was replaced with new one but it was loosened during rod fixation.The screw was replaced again and a complaint was opened.The surgery was anyway completed successfully without critical delay.

• Brand Name: MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15824408
• MDR Text Key: 303900186
• Report Number: 3005180920-2022-00844
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630971278462
• UDI-Public: 07630971278462
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.57.035
• Device Catalogue Number: 03.57.035
• Device Lot Number: 2222997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2022
• 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
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian