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

Catalog Number	03.52.323
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9465003
• Report Number: 3005180920-2019-01061
• Device Sequence Number: 2107105
• Product Code: NKB
• UDI-Device Identifier: 07630030857584
• UDI-Public: 07630030857584
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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 Expiration Date: 02/18/2024
• Device Catalogue Number: 03.52.323
• Device Lot Number: 1920189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/13/2019
• 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