MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.58.246 MUST MC SCREW Ø6X50 CANNULATED; SPINE PEDICLE SCREW

Catalog Number	03.58.246
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery about 1 year and 2 months after the primary surgery due to the breakage of two must mc screws on the l5 segment.The primary surgery involved two segments: l4-l5.There was no reported fall or clearly identified trauma.The patient experienced pain at the beginning of this year.X-rays revealed the breakage of one screw, although the surgeon was unable to locate the second breakage.During the surgery, both broken screws were observed, both located on the l5 segment.Both screws broke at the junction of the head and the body of the screw.No osteointegration of the screws in l5.
Additional Manufacturer Narrative
Batch review performed on 22 march 2024.Lot 2224955: (b)(4) items manufactured and released on 19-jul-2022.Expiration date: 2027-jul-03.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.Clinical evaluation performed by medical affairs department: revision surgery was performed 14 months after a primary l4-l5 circumferential stabilization using screws, rods (must mc system, polyaxial cannulated screws), and a competitor intervertebral cage.The reason for the revision was the bilateral breakage of the l5 screws.The patient reported pain and underwent a follow-up x-ray examination in (b)(6) 2024, which revealed the breakage of the right l5 screw (while the left l5 screw breakage was detected intraoperatively).The x-rays additionally indicate the l4 screws appear to be slightly short and it is challenging to discern signs of osseous fusion.Pedicle screws often suffer fatigue fractures when fusion did not take place and the device is continuously stressed: this is likely to be the clinical cause for fracture, but based on the information available, it is difficult to determine the cause of the lack of fusion (the biological characteristics of the patient may also play a role).Preliminary evaluation performed by r&d project manager: according to the pictures received, two screws broke in the area under the neck, compatible with flexional fatigue.It is possible that the conditions reported in the clinical evaluation led to excessive stress on the implants and consequent failure.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager two screws broke in the area under the neck, compatible with flexional fatigue.It is possible that the conditions reported in the clinical evaluation led to excessive stress on the implants and the consequent breakage.

• Brand Name: PEDICLE SCREW 03.58.246 MUST MC SCREW Ø6X50 CANNULATED
• 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: 19077468
• Report Number: 3005180920-2024-00180
• Device Sequence Number: 15058972
• Product Code: NKB
• UDI-Device Identifier: 07630971293588
• UDI-Public: 07630971293588
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K210427
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2024

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 Catalogue Number: 03.58.246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 90 KG