MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM; SPINE POLY-AXIAL PEDICLE SCREW

Model Number	03.52.322
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2022.Lot 2221113: (b)(4) items manufactured and released on 09-mar-2022.Expiration date: 2027-feb-22.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 (2 devices reported in this complaint).
Event or Problem Description
L4/5 fixation surgery.The patient's pedicles on l4 broke during screw insertion.Larger size screws was used to complete the surgery.The surgeon drill the hole, then 5 mm tapping and 6 mm tapping.K-wire was used.Bone quality normal.No skiving problem occurred during insertion.
Event or Problem Description
L3-l4 fixation surgery.The patient's pedicles on l3 broke during screw insertion.Larger size screws was used to complete the surgery.The surgeon drill the hole, then 5 mm tapping and 6 mm tapping.K-wire was used.Bone quality normal.No skiving problem occurred during insertion.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the pedicle screw (ref.03.52.322, lot 2221113) has been analyzed and is conforming to specification.The myspine planning has been reviewed and no anomalies were found.No root cause can be defined.Mysolution department evaluation: the analysis of the myspine process of this case found no deviations from the standard procedures.Each step has been performed correctly.

• Brand Name: PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM
• Common Device Name: SPINE POLY-AXIAL 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16021055
• Report Number: 3005180920-2022-00978
• Device Sequence Number: 5884089
• 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
• 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): 02/09/2023

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 Model Number: 03.52.322
• Device Catalogue Number: 03.52.322
• Device Lot Number: 2221113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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