MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM; SPINE POLYAXIAL PEDICLE SCREW

Catalog Number	03.52.322
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2023.Lot 2122647: (b)(4) items manufactured and released on 06-jul-2021.Expiration date: 2026-06-11.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.Only one screw was involved but it is unknown which one.Here below all the screws implanted during the primary: batch review performed on 02 november 2023 on pedicle screw 03.52.322 enh.Poly-axial.Pedicle screw - cannulated 6x35mm (k141988) lot.2123664.Lot 2123664: (b)(4) items manufactured and released on 20-sept-2021.Expiration date: 2026-09-01.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.Batch review performed on 02 november 2023 on pedicle screw 03.52.322 enh.Poly-axial pedicle screw - cannulated 6x35mm (k141988) lot.2227714 lot 2227714: (b)(4) items manufactured and released on 16-nov-2022.Expiration date: 2027-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Two devices involved in this event.Batch review performed on 02 november 2023 on pedicle screw 03.52.323 enh.Poly-axial pedicle screw - cannulated 6x40mm (k141988) lot.2227715.Lot 2227715: (b)(4) items manufactured and released on 22-nov-2022.Expiration date: 2027-11-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Two devices involved in this event.
Event or Problem Description
At 6 months from the primary, the patient came in for a post-op appointment and one of the six screws was observed to be broken at the bottom of the construct.It is unknown how/why this occurred.A revision surgery has not been scheduled yet.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Common Device Name: SPINE POLYAXIAL 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: 18191989
• Report Number: 3005180920-2023-00916
• Device Sequence Number: 7215726
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• 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
• 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): 11/22/2023

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 Expiration Date: 06/11/2026
• Device Catalogue Number: 03.52.322
• Device Lot Number: 2122647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2021
• 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: Unknown