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

Catalog Number	03.52.314
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05-jan-2024.Lot 2125448: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-10-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review with two items involved in that event with this lot.Additional implants involved: pedicle screw 03.52.315 enh.Poly-axial pedicle screw - cannulated 5x45mm (k141988) lot 2127130 batch review performed on 05-jan-2024, lot 2127130: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-12-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events during the period of review.Pedicle screw 03.52.324 enh.Poly-axial pedicle screw - cannulated 6x45mm (k141988) lot 2220280 batch review performed on 05-jan-2024, lot 2220280: (b)(4) items manufactured and released on 01-mar-2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events during the period of review.This complaint involves two items with this lot.Myspine 7.0724 myspine-mc drill guide l04 (k173472) lot.11419s 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.We reproduced the l04 guide and the bone model, the fitting check and the result is conform; the guide is stable and has a good docking.The batch review performed did not reveal any anomaly.Surgeon feedback: the severely overgrown facet displaced the guide slightly and ended up with a pilot hole that was too medial.It was immediately recognized and able to be re-directed with end construct being perfect.Unfortunately the patient developed a delayed radiculitis, which required a return to the or and had to reduce a herniated nerve rootlet through the small durotomy.
Event or Problem Description
The severely overgrown facet displaced the guide slightly and ended up with a pilot hole that was too medial.It was immediately recognized and able to be re-directed with end construct being perfect.Unfortunately the patient developed a delayed radiculitis, which required a return to the or and had to reduce a herniated nerve rootlet through the small durotomy.

• Brand Name: ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
• Common Device Name: 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: 18481932
• Report Number: 3005180920-2023-01099
• Device Sequence Number: 21101848
• 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): 01/10/2024

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: 03.52.314
• Device Lot Number: 2125448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/10/2024
• 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 Sex: Male