MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM; SPINE PEDICLE SCREW

Catalog Number	03.52.336
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 october 2023: lot 2221122: (b)(4) items manufactured and released on 07-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 any similar reported event in the period of review.Mysolution analysis: our analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.
Event or Problem Description
During final tightening with the rod at s1 right side (myspine case), the pedicle screw mobilized after the fracture of the patient bone.Another pedicle screw has been implanted with a different trajectory and the surgery was completed successfully.It has been reported that the patient bone was weak.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: no visible defect can be seen on the implant.The root cause for the screw backout is the fracture of the bone, that may be caused by weak skeletal quality.

• Brand Name: PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM
• 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: 18021798
• Report Number: 3005180920-2023-00825
• Device Sequence Number: 7593354
• Product Code: NKB
• UDI-Device Identifier: 07630030857744
• UDI-Public: 07630030857744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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 Catalogue Number: 03.52.336
• Device Lot Number: 2221122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian