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

Model Number 03.52.322

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/15/2021

Event Type  Injury  

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 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
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12133767
• MDR Text Key: 260438032
• Report Number: 3005180920-2021-00569
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030857577
• UDI-Public: 07630030857577
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.52.322
• Device Catalogue Number: 03.52.322
• Device Lot Number: 2021937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other