MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REDUCTION CANNULATED PEDICLE SCREW 5X45; SPINE PEDICLE SCREW

Model Number	03.52.712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, it was difficult to fit the l2 guide to the bone.Delay time was 30min.The surgeon confirmed that the screw had come off by post-op ct image.A second surgery was immediately performed, the screw was removed, and refixation was performed.The spinous process was excised as indicated in the planning.
Additional Manufacturer Narrative
Additional items involved in the event: myspine 7.0722 myspine mc drill based guide l02 (k173472) lot.08794s.Myspine 7.0702 myspine mc vertebra l02 (k173472) lot.08794s.Batch review performed on 30 january 2023.Lot 08794s: (b)(4) items manufactured and released on 30 january 2023.No anomalies found related to the problem.Mysolution department analysis.Our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.Guides were reprinted and tested with positive results.In particular, the l02 guide is very stable, thanks in part to the cranial arch, and consistent with all the preferences requested by the surgeon.The guide used during surgery and the bone model were sent back for analysis and were tested with positive results: the fitting is stable and univocal without any slipping problems.It is evident the correct fit with the trajectory of the holes ('left hole' and 'right hole') and the correct positioning of the pads in 3 different views.

• Brand Name: REDUCTION CANNULATED PEDICLE SCREW 5X45
• 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: 16395234
• Report Number: 3005180920-2023-00075
• Device Sequence Number: 6433257
• Product Code: NKB
• UDI-Device Identifier: 07630030847080
• UDI-Public: 07630030847080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 02/17/2023

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: 03.52.712
• Device Catalogue Number: 03.52.712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian