MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM; SPINE PEDICLE SCREW

Catalog Number	03.52.321
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to lack of fusion on left l5/s1.It is unknown why this occurred.At 1 year and 4 months post primary the surgeon removed all implants and reimplanted new implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26-apr-2024: lot 2023987: (b)(4) items manufactured and released on 19-jan-2021.Expiration date: 2025-12-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implants involved, batch review performed on 26-apr-2024: pedicle screw 03.52.321 enh.Poly-axial pedicle screw - cannulated 6x30mm (k141988) lot 2124253: (b)(4) items manufactured and released on 06-sep-2021.Expiration date: 2026-08-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.322 enh.Poly-axial pedicle screw - cannulated 6x35mm (k141988) lot 2126410: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-11-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x35mm (k141988) lot 2124566: (b)(4) items manufactured and released on 20-sep-2021.Expiration date: 2026-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.324 enh.Poly-axial pedicle screw - cannulated 6x45mm (k141988) lot 2220280: (b)(4) items manufactured and released on 01-mar-2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.324 enh.Poly-axial pedicle screw - cannulated 6x45mm (k141988) lot 2221117: (b)(4) items manufactured and released on 15-mar-2022.Expiration date: 2027-02-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported events during the period of review (all the implants are involved in this complaint).Pedicle screw 03.52.440 enh.Bent rod ti 5.5x120mm (k141988) lot 1620072c: (b)(4) items reworked and released on 25-jan-2021.Expiration date: 2026-01-10.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Pedicle screw 03.52.440 enh.Bent rod ti 5.5x120mm (k141988) lot 2126706: (b)(4) items manufactured and released on 09-feb-2022.Expiration date: 2027-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19307529
• Report Number: 3005180920-2024-00309
• Device Sequence Number: 15048267
• Product Code: NKB
• UDI-Device Identifier: 07630030857560
• UDI-Public: 07630030857560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 12/20/2025
• Device Catalogue Number: 03.52.321
• Device Lot Number: 2023987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female