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
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15824408
• Report Number: 3005180920-2022-00844
• Device Sequence Number: 6157337
• Product Code: NKB
• UDI-Device Identifier: 07630971278462
• UDI-Public: 07630971278462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 11/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 03.57.035
• Device Catalogue Number: 03.57.035
• Device Lot Number: 2222997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2022
• 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: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian