MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT; POLYAXIAL SPINE SCREW

Model Number	03.75.002
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2020: lot 1923117: 150 items manufactured and released on (b)(6) 2019.Expiration date: 2024-10-14.No anomalies found related to the problem.To date, 59 items of the same lot have been already sold without any similar reported event.Visual inspection based on the event description, it is assumed that the pull out of the screw from the vertebrae during the rod reduction was due to poor quality of the bone, that could lead to osteophorotic bone.This kind of risk is known in spinal system application.In similar circumstances, it is preferred to use larger screws diameter like 4mm or 4.5mm, in order to improve the pull out strength at the implant-bone interface.In addition, even longer screw could help in preventing such a issue.In fact, larger ang longer screws are available in the overall screws product range.During the visual inspection performed on the retrieved screw, no negative aspect like sign, defect, and thread profile deterioration were noted.The thread profile was virgin and equivalent to the ones of screw on stock.Preliminary investigation and visual inspection were performed on (b)(6) 2020.
Event or Problem Description
Spinal fixation was performed at c2-t2.Open surgery.The bone quality seemed to be low.When the surgeon engaged the cervical screw with the rod at left side of c2, the cervical screw was pulled out from the patient body because the cervical screw was not able to withstand the load.The surgeon decided to do not implant the screw in c2 left.Due to this event the surgery was prolonged about 30 minutes.Total surgery time was 280mins.

• Brand Name: MUST MINI POLYAXIAL SCREW 3.5 X 14 FULL THREAD + NUT
• Common Device Name: POLYAXIAL SPINE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10905039
• Report Number: 3005180920-2020-00821
• Device Sequence Number: 3045590
• Product Code: NKG
• UDI-Device Identifier: 07630030863165
• UDI-Public: 07630030863165
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K171369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2024
• Device Model Number: 03.75.002
• Device Catalogue Number: 03.75.002
• Device Lot Number: 1923117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR