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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

Batch review not performed since lot is not available.

Event 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.

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)
• Type of Device: 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
• MDR Text Key: 301640213
• Report Number: 3005180920-2022-00779
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630040716086
• UDI-Public: 07630040716086
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171758
• 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,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White