MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.314 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM; SPINE PEDICLE SCREW

Model Number	03.52.314
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 march 2023: lot 2125448: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-oct-28.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: a few days after primary lumbar posterior stabilization surgery, the surgeon finds that two pedicle screws are in fact outside of the vertebral body.We do not know if this situation was already present right after surgery or if it was an evolutionary status.In the former case, we have no information as to why no action was taken during primary surgery.In the latter case, we have no viable hypothesis to offer as to the mechanics of such unfavorable evolution.We can hardly imagine that this is due to a defective device.Mysolution planning review: our analysis of the myspine process in this case found no deviations from the standard procedures.Each step has been performed correctly.We reprinted the guides l02 and l03 and confirmed that the fitting is stable and univocal.Other device involved: pedicle screw 03.52.314 enh.Poly-axial pedicle screw - cannulated 5x40mm (k141988) lot 2125448: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-oct-28.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
About 12 days after the primary surgery, the patient came in for a post-op appointment and it was observed that the right l2 and l3 screws were outside the vertebral body.The screws were probably misplaced during the primary surgery; although the position was checked during surgery with fluoroscopy.The surgeon revised the 2 misplaced screws and the surgery was completed successfully.Patient with scoliosis.No issue with the myspine guides occurred during the primary surgery.

• Brand Name: PEDICLE SCREW 03.52.314 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
• 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: 16741313
• Report Number: 3005180920-2023-00272
• Device Sequence Number: 6642136
• Product Code: NKB
• UDI-Device Identifier: 07630030857461
• UDI-Public: 07630030857461
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 03.52.314
• Device Catalogue Number: 03.52.314
• Device Lot Number: 2125448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White