MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA M.U.S.T. PEDICLE SCREW

Catalog Number 03.50.017

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Pain (1994); Staphylococcus Aureus (2058); Sweating (2444)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 february 2016.Lot 155058: (b)(4) items manufactured and released on 11 september 2015.Expiration date: 2020-08-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.This report involves (b)(4) items of the same lot, but no other similar events has been reported on items of the same lot.M.U.S.T.Pedicle screw set screw code 03.50.200, lot.152347 ((b)(4) ) (b)(4) items manufactured and released on 12 may 2015.Expiration date: 2020-04-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.M.U.S.T.Pedicle screw pedicle screw 6x40, code 03.50.017, lot.123733 ((b)(4)) (b)(4) items manufactured and released on 10 september 2012.Expiration date: 2017-07-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.M.U.S.T.Pedicle screw pedicle screw 6x40, code 03.50.017, lot.131110 ((b)(4) ) (b)(4) items manufactured and released on 08 march 2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.M.U.S.T.Pedicle screw bent rod ti 5.5 x 40mm, code 03.50.451, lot.144721 ((b)(4)) (b)(4) items manufactured and released on 13 january 2015.Expiration date: 2019-11-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.This report involves 2 items of the same lot, but no other similar events has been reported on items of the same lot.On (b)(4) 2016 it was prepared a final report with the information submitted in this intial report.On (b)(4) 2016 the report was sent to the initial reporter and the case was closed.

Event Description

The patient was having pain and swelling.The surgeon removed the 2 rods and 4 screws due to an infection of (b)(6).The surgery was completed successfully.The explants will not be returned.There are no x-rays.

• Brand Name: M.U.S.T. PEDICLE SCREW
• 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, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5412695
• MDR Text Key: 37543639
• Report Number: 3005180920-2016-00019
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K121115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: 03.50.017
• Device Lot Number: 155058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2015
• 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 Age: 66 YR