MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.415 ENH. ROD TI 5.5X200MM; SPINE ENH. ROD TI

Model Number	03.52.415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-apr-2023; lot 2121497: (b)(4) items manufactured and released on 23-jul-2021.Expiration date: 2026-07-07.No anomalies found related to the problem.To date, 51 items of the same lot have been sold with no similar reported case during the period of the review.Clinical evaluation performed by medical affairs director: one year after thoraco-lumbar fusion on 4 levels one of the rods broke and needed exchanging.We have no history of the case and the one picture supplied is of extremely low quality, so that it's impossible to offer a thorough reconstruction of the case.It can be assumed that it originated from a vertebral fracture which did not heal completely after one year.In these conditions, the temporary implants are subject to fatigue failure.In this case, the necessity of bridging the broken vertebra exposed the rod to an increased stress and, coupled with the lack of fusion at 12 months, fracture occurred.Visual inspection performed by r&d manager: as can be seen in the x-ray and in picture sent, the rod broke.The construct is made of 4 screws that cover 5 vertebrae, with the central vertebra without screw.The cracking happened adjacent to the two upper pedicle screws, on the side facing the not supported area.It is unknown if any traumathic event that may have reduced the strength of the implant occurred.The root cause may have been a lack bone fusion combined with the missing support of a screw in the level adjacent to the breakage plane.
Event or Problem Description
Revision surgery at about 1 year and 1 month after primary due to enh.Rod ti 5.5x200mm breakage while the patient was sitting.

• Brand Name: PEDICLE SCREW 03.52.415 ENH. ROD TI 5.5X200MM
• Common Device Name: SPINE ENH. ROD TI
• 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: 16831295
• Report Number: 3005180920-2023-00314
• Device Sequence Number: 1929666
• Product Code: NKB
• UDI-Device Identifier: 07630030858086
• UDI-Public: 07630030858086
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 07/07/2026
• Device Model Number: 03.52.415
• Device Catalogue Number: 03.52.415
• Device Lot Number: 2121497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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 Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic