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

Model Number	03.52.322
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021 lot 2021937: 100 items manufactured and released on 02-sep-2020.Expiration date: 2025-08-25.No anomalies found related to the problem.To date, 64 items of the same lot have been sold without any similar reported event.In the event are reported two items with the same lot.Analysis performed by r&d department: our analysis of the myspine process of this case found no deviations from the standard procedures.The reconstruction is precise and correct, all areas were clearly identifiable.The reconstructed profile accurately follows the contour of s01 vertebra.The surgeon validated the planning.The guide was designed according to the trajectory of the screws in the planning validated.There was a big interference between l05 vertebra and s01 guide which could compromise the guide's correct positioning.For this reason, we have designed s01 guide considering a partial facetectomy of l05 left and right inferior articular processes.
Event or Problem Description
1 week after the primary myspine surgery a s1 bone fracture line was detected through the ct.No additional surgery planned at the moment.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12133767
• Report Number: 3005180920-2021-00569
• Device Sequence Number: 17069905
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/08/2021

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: 08/25/2025
• Device Model Number: 03.52.322
• Device Catalogue Number: 03.52.322
• Device Lot Number: 2021937
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other