MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST PEDICLE SCREW 8X40MM

Catalog Number 03.50.054

Device Problem Device Issue (2379)

Patient Problems Arthritis (1723); Pain (1994)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 20 november 2017.Lot 160534: (b)(4) items manufactured and released on 07 march 2016.Expiration date: 2021-02-15.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.Must pedicle screw 7x50mm, code 03.50.032, lot.160531 (k121115).(b)(4) items manufactured and released on 11 march 2016.Expiration date: 2021-02-01.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.Must pedicle screw 7x45mm, code 03.50.031, lot.165548 (k121115) (b)(4) items manufactured and released on 28 november 2016.Expiration date: 2021-11-06.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.Must pedicle screw 7x50mm, code 03.50.032, lot.161898 (k121115) (b)(4) items manufactured and released on 30 may 2016.Expiration date: 2021-04-06.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.Must pedicle screw 8x40mm, code 03.50.054, lot.153403 (k132878) (b)(4) items manufactured and released on 06 july 2017.Expiration date: 2020-06-03.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.

Event Description

The patient had a primary fusion of l3-s1.The patient came in complaining of right leg pain and lower back pain.The patient presented with pseudo arthritis.The surgeon determined that the screws backed out.The surgeon revised all medacta screws and rods.The surgery was completed successfully.

• Brand Name: MUST PEDICLE SCREW 8X40MM
• 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
• MDR Report Key: 7052116
• MDR Text Key: 92723715
• Report Number: 3005180920-2017-00688
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030834417
• UDI-Public: 07630030834417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132878
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 03.50.054
• Device Lot Number: 160534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2016
• 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