MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°; SPINE TIPEEK CAGE

Catalog Number	03.26.256
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 9 months from the primary, the patient came in for a post-op appointment and there was a non-union of the vertebras.The surgeon removed all components except the ø7x45 pedicle screws.The surgery was completed successfully.The bone was osteoporotic and the patient was overall unhealthy.
Additional Manufacturer Narrative
Batch review performed on 04 june 2024: lot 2122238: (b)(4) items manufactured and released on 18-oct-2021.Expiration date: 2026-09-29.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 devices involved: batch reviews performed on 04 june 2024: pedicle screw 03.52.455 enh.Bent rod ti r100 5.5x45mm (k141988) lot 1620075b: (b)(4) items manufactured and released on 21-jun-2022.Expiration date: 2027-05-31.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 03.52.456 enh.Bent rod ti r100 5.5x50mm (k141988) lot 1620076b: (b)(4) items manufactured and released on 20-dec-2022.Expiration date: 2027-12-01.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.Must lt 03.59.034 must lt 15mm long - pedicle screw ø7x40 cann (k203482) lot 2022534: (b)(4) items manufactured and released on 01-march-2021.Expiration date: 2026-02-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported events during the period of review.(2 devices involved in this complaint).

• Brand Name: MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°
• Common Device Name: SPINE TIPEEK CAGE
• 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: 19605509
• Report Number: 3005180920-2024-00443
• Device Sequence Number: 6334901
• Product Code: MAX
• UDI-Device Identifier: 07630971290587
• UDI-Public: 07630971290587
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/25/2024

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: 09/29/2026
• Device Catalogue Number: 03.26.256
• Device Lot Number: 2122238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG