MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 7X40; SPINE PEDICLE SCREW

Model Number	03.50.030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 october 2020: lot 1921261: (b)(4) items manufactured and released on 30-sep-2019.Expiration date: 2024-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d spine manager: the pedicle screw 03.50.030, lot 1921261, has some small deformation on the thread of the tulip.It's possible to assemble the setscrew on te tulip but with some friction.There is no non conformities associated to this lot.The potential root cause of the event is a crossthreading during the primary surgery or revision surgery.The reference and the lot of the screw malpositioned is unknown.
Event or Problem Description
It was a revision surgery 1 week after primary because the surgeon recognized a screw malposition.It was not a myspine case.Another screw already placed in the primary surgery was fine but, when the surgeon tried to insert the new set screw, he notice that the thread was partially damaged and therefore it was impossible to insert the nut.It is unknown if the damage to the tulip happened during revision or during the primary.He removed the screw and changed it with a new sterile screw.The screw inserted in the claim refers to the screw with damaged thread.There is no info on the repositioned one.

• Brand Name: PEDICLE SCREW 7X40
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10640770
• Report Number: 3005180920-2020-00679
• Device Sequence Number: 4044216
• Product Code: KWP
• UDI-Device Identifier: 07630030834288
• UDI-Public: 07630030834288
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: 03.50.030
• Device Catalogue Number: 03.50.030
• Device Lot Number: 1921261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 10/07/2020
• 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; Required Intervention