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

Catalog Number	03.50.054
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Arthritis (1723); Pain (1994)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7052116
• Report Number: 3005180920-2017-00688
• Device Sequence Number: 13469635
• Product Code: NKB
• UDI-Device Identifier: 07630030834417
• UDI-Public: 07630030834417
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 03.50.054
• Device Lot Number: 160534
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention