MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW LATERAL CONNECTOR L150

Catalog Number	03.56.106
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-nov-2023.Lot 2023628: (b)(4) items manufactured and released on 05-jul-2021.Expiration date: 2026-06-08.No anomalies found related to the problem.To date, 07 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a l2-ilium fusion was performed as revision surgery using must screw system and tlif cage (likely at l5-s1 level).After less than 6 months (date unspecified), the patient complained of back pain and underwent x-ray, showing on the right side the breakage of the rod at lumbo-sacral junction and s1 screw.On the left side a long lateral connector (150 mm, ref.03.50.106) was used as longitudinal rod from l2 to the sacrum and engaged with a short horizontal rod, up to the left iliac screw.This unusual construct broke as well before fusion occurred.Moreover, the patient is reported to be overweight (97 kg), heavy smoker and with multiple comorbidities.All these are described in the literature as risk factors for fusion failure.So, the breakeage could have been caused by cumulation of several risk factors: the overload of the system at the lumbo-sacral junction, lateral connector used longitudinally, lack of osseous fusion (due to patients characteristics), reduced lumbo-sacral lordosis.With the information at hand, it would be difficult to suspect a defective or malfunctioning device.Additional implants involved, batch review performed on 20-nov-2023.Pedicle screw 03.50.016 pedicle screw 6x35 (k121115) lot 2123375: (b)(4) items manufactured and released on 20-jul-2021.Expiration date: 2026-07-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Pedicle screw 03.50.801 anodized rod ti 5.5x200 (k162061) lot 1922359: (b)(4) items manufactured and released on 30-aug-2019.Expiration date: 2024-07-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
Revision surgery performed due to pain, the lateral cross-connector, the right rod and a pedicle screw were broken, 5 months after the previous revision surgery (t-lif surgery, the patient had expedium system from depuy synthes).

• Brand Name: PEDICLE SCREW LATERAL CONNECTOR L150
• Common Device Name: LATERAL CONNECTOR
• 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: 18317804
• Report Number: 3005180920-2023-00977
• Device Sequence Number: 14990651
• Product Code: NKB
• UDI-Device Identifier: 07630345703231
• UDI-Public: 07630345703231
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K203482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2023

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: 07/01/2026
• Device Catalogue Number: 03.56.106
• Device Lot Number: 2023628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 97 KG