MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM; SPINE PEDICLE SCREW

Catalog Number	03.52.314
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
2 pedicle cannulated screws were found loose during revision surgery for patient's back pain (10 months post primary).Level l4-l5.
Additional Manufacturer Narrative
Batch review performed on (b)(6), 2023: lot 2020775: (b)(4), manufactured and released on 25-may-2020.Expiration date: 2025-05-05.No anomalies found related to the problem.To date, (b)(4), of the same lot have been sold without any similar reported event in the period of review.Additional involved implant: batch review performed on (b)(6), 2023 on pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm (k141988) lot.2125837 lot 2125837: (b)(4), manufactured and released on 16-nov-2021.Expiration date: 2016-10-26.No anomalies found related to the problem.To date, (b)(4), of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
• 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: 17389620
• Report Number: 3005180920-2023-00540
• Device Sequence Number: 3875195
• Product Code: NKB
• UDI-Device Identifier: 07630030857461
• UDI-Public: 07630030857461
• 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: 2023
• 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): 07/25/2023

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: 05/05/2025
• Device Catalogue Number: 03.52.314
• Device Lot Number: 2020775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2020
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG