MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X); SPINE SET SCREW PEDICLE SCREW

Catalog Number	03.50.204
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed a few days after an l3-l4 stabilization procedure.The reported reason for the revision was loosening of one set screw and the tlif cage.The patient experienced a fall during rehabilitation, and a radiological follow-up revealed the failure.Setscrew and cage were successfully revised.
Additional Manufacturer Narrative
Batch review performed on 18 september 2024.Lot 2459779: (b)(4) items manufactured and released on 21-june-2024.Expiration date: 2029-05-30.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.Batch review performed on 18 september 2024 on the other component involved in the event: mectalif transforaminal (ti peek) 03.23.151 transforaminal interbody fusion device tipeek 12x30x8 l5° (k200551) lot 2120811: (b)(4) items manufactured and released on 02-sep-2021.Expiration date: 2026-07-22.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.Clinical evaluation.A revision surgery was performed a few days after an l3-l4 stabilization procedure.The reported reason for the revision was loosening of one set screw and the tlif cage.The patient experienced a fall during rehabilitation, and a radiological follow-up revealed the failure.From the available x-ray and ct images, it is evident that one set screw on l4 was not fully seated and appeared tilted, while the cage was misaligned, showing lateralization and rotation.The surgeon suspected that the set screw may have been improperly tilted from the beginning, unable to be fully tightened into its position.This could have led to some degree of instability in the construct, potentially worsened by the patient's fall, which also resulted in cage displacement.There is no indication to suggest a defective or malfunctioning device, also considering that the picture of the subjected device did not reveal signs of damage.Pictures analysis: the tlif cage 03.23.151, lot no.2120811, shows no signs of damages from the pictures received.Considering the description of the event the root cause of the complaint could be the loosening of one setscrew that led to an instability of the construct.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
• Common Device Name: SPINE SET SCREW 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: 20308719
• Report Number: 3005180920-2024-00779
• Device Sequence Number: 8883257
• Product Code: NKB
• UDI-Device Identifier: 07630040716086
• UDI-Public: 07630040716086
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 09/26/2024

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: 03.50.204
• Device Lot Number: 2459779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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 Ethnicity: Non Hispanic
• Patient Race: White