MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM; SPINE PEDICLE SCREW

Model Number	03.52.324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 october 2022: lot 2126415: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-nov-16.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.
Event or Problem Description
The lower edge of the pedicle on both sides of l5 fractured during screw insertion in the cortical bone trajectory.On the left, the lower edge of the pedicle was slightly cracked, and on the right, the entire lower edge of the pedicle was cracked.Bone quality was normal.The surgeon used myspinemc guide.He did a 5mm under drill, then a 5mm tap with a guide wire, and then a 6 mm tap.One side still seemed to be fixed, so the screw was left as it was.The fracture on the other side was large and the larger screw was inserted into the pedicle screw trajectory.
Additional Manufacturer Narrative
The item involved in the complaint has been returned on october 26th 2022.Visual inspection performed by r&d project manager.The reported issue seems to be associated more with the position of the screw than with the screw itself.Analyzing the myspine surgical planning report it can be observed that is mentioned a potential pedicle breaching in both the pedicles in l5 vertebra based on the users modifications between the revision zero and one of the planning.The event reported "the lower edge of the pedicle on both sides of l5 fractured during screw insertion in the cbt trajectory" is compatible with the warning reported in the myspine surgical planning report.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: this complaint refers to a lumbar stabilization surgery.The surgeon planned for a 6 mm screw (comparatively large) to be placed very near the edge of the pedicles: he was most probably seeking to give the best possible stability, using a cortical-based trajectory and the largest possible screw.The planning system warned that the screws were likely to breach the pedicle but, certainly for medical reasons, the surgeon decided to maintain the plan.The patient-specific guides were manufactured accordingly.In these conditions, one of the pedicles fractured but the screw was judged to be soundly placed anyway.On the other side, the fracture of the pedicle limited the stability of the screw and therefore the surgeon decided to follow the traditional divergent path.No adverse clinical consequence should be expected from this change of surgical strategy, justified by the conditions detected during surgery.No reason to suspect a malfunctioning device.Visual inspection performed by r&d spine manager: during visual inspection, the pedicle screw (ref.(b)(4), lot 2126415) has been analyzed and is conform to specification.The myspine planning has been reviewed and no anomalies were found.The reported event may be related to many factors, including the need to place the screw very close to the cortical, increasing the likelihood of bone fracture.No definitive root cause can be established.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15664975
• Report Number: 3005180920-2022-00805
• Device Sequence Number: 12318383
• Product Code: NKB
• UDI-Device Identifier: 07630030857591
• UDI-Public: 07630030857591
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

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 Model Number: 03.52.324
• Device Catalogue Number: 03.52.324
• Device Lot Number: 2126415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 10/04/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/15/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian