MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1

Catalog Number 03.52.323

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 december 2019: lot 1920189: (b)(4) items manufactured and released on 07-mar-2019.Expiration date: 2024-02-18.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.Other devices involved in the event: pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm lot.1621605 (k141988) batch review performed on 02 december 2019: lot 1621605: (b)(4) items manufactured and released on 01-sept-2017.Expiration date: 2022-07-23.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.Pedicle screw 03.52.321 enh.Poly-axial pedicle screw - cannulated 6x30mm lot.1822721 (k141988).Batch review performed on 02 december 2019: lot 1822721: (b)(4) items manufactured and released on 19-dec-2018.Expiration date: 2023-12-06.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.Pedicle screw 03.52.322 enh.Poly-axial pedicle screw - cannulated 6x35mm lot.1920767 (k141988).Batch review performed on xx december 2019: lot 1920767: (b)(4) items manufactured and released on 28-mar-2019.Expiration date: 2024-03-12.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.Pedicle screw 03.52.336 enh.Poly-axial pedicle screw - cannulated 7x35mm lot.149086 (k141988).Batch review performed on 02 december 2019: lot 149086: (b)(4) items manufactured and released on 20-feb-2015.Expiration date: 2020-02-03.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.Pedicle screw 03.52.336 enh.Poly-axial pedicle screw - cannulated 7x35mm lot.1621386 (k141988).Batch review performed on 02 december 2019: lot 1621386: (b)(4) items manufactured and released on 23-mar-2017.Expiration date: 2022-02-15.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.Pedicle screw 03.52.432 enh.Bent rod ti 5.5x80mm lot.1721266 (k141988).Batch review performed on 02 december 2019: lot 1721266: (b)(4) items manufactured and released on 28-sept-2018.Expiration date: 2023-09-17.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

1 month post primary the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the set screws and rod.The surgery was completed successfully.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9465003
• MDR Text Key: 185726880
• Report Number: 3005180920-2019-01061
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141988
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1920189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2019
• 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