MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X); SPINE PEDICLE SCREW SET SCREW

Model Number	03.50.206
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review not performed since lot is not available.
Event or Problem Description
Loosening of the setscrew 3 months after the primary surgery.The surgeon expects that there was not due to an implant failure rather a personal error.The setscrew was changed and properly fixed.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.Mobilization of set screw in a 2 level lumbar stabilization treatment 3 months after surgery.Explants were not returned, therefore no technical examination could be run.The most probable cause is insufficient tightening torque.Sometimes the surgeons is afraid of creating damages to the bone or surrounding tissues by excessive tightening.A final conclusion cannot be drawn with the elements at hand.Visual inspection performed by r&d project manager.During the visual inspection, it has been performed the analysis of the must combined setscrew, ref.03.50.204, lot: 2221847.The device is according to the specification for the dimensional and functional point of view.No ncs are associated to the lot.A functional test has been performed with the device on a brand new pedicle screw with positive results.Batch review performed on 19-oct-2022.Lot: 2221847: (b)(4) items manufactured and released on 31-mar-2022.Expiration date: 2027-03-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
• Common Device Name: SPINE PEDICLE SCREW SET 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: 15594877
• Report Number: 3005180920-2022-00779
• Device Sequence Number: 2315386
• Product Code: NKB
• UDI-Device Identifier: 07630040716086
• UDI-Public: 07630040716086
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2022

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: 03.50.206
• Device Catalogue Number: 03.50.204
• Device Lot Number: 2221847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White