MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 8X40MM

Model Number 03.50.054

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 july 2020: lot 1924057: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-08.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.Other devices involved in the event pedicle screw 03.56.404 must straight cross connector 40mm lot.1720364 (k171170).Batch review performed on 30 july 2020 lot 1720364: (b)(4) items manufactured and released on 19-jul-2017.Expiration date: 2022-07-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with two other similar reported events.

Event Description

Spinal fixtaion was performed at l2-l5 firstly.The surgeon engaged the pedicle screw with the screw driver, but he felt the engage strength of the pedicle screw and the screwdriver might be weak.After the insertion of the pedicle screw and the rod, the surgeon felt the loosening of the pedicle screw at the left side of the l5, so the surgeon replaced the pedicle screw and the rod and performed the additional spinal fixtaion.Moreover when the surgeon engaged the cross connector, the arm of the cross connector contacted to the lamina.In order to use it the surgeon performed additional lamina cut.The surgeon did not use the cross connector because the surgeon would like to avoid additional cut.Finally, l2-s1 was fixed.Due to this event the surgery was prolonged about 25 minutes.Total surgery time was about 150mins.

Manufacturer Narrative

Visual inspection.During the visual inspection, it has been analized: the pedicle screw, ref.03.50.054, lot.1924057; the bent rod, ref.03.52.442, lot.1620911; the must straight cross connector, ref.03.56.404, lot.1720364; the polyaxial screwdriver reduction, re.03.51.10.0222, lot 1850161.All the implants analized didn't present any damaging or unfunctionality, except the must straight cross connector for which is missed a screw.The instrument analized didn't present any damaging or unfunctionality.The functionality between the pedicle screw and the polyaxial screwdriver reduction has been test and the fixation is stable.The must straight cross connector has small encumbrance but it shoulf be available as alternative the must link cross connector that can give to the surgeon addiotnal option to avoid lamina cut.Visual inspection performed on august the 31st, 2020.

• Brand Name: PEDICLE SCREW 8X40MM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10389668
• MDR Text Key: 203305952
• Report Number: 3005180920-2020-00506
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07630030834417
• UDI-Public: 07630030834417
• Combination Product (y/n): N
• PMA/PMN Number: K132878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 03.50.054
• Device Catalogue Number: 03.50.054
• Device Lot Number: 1924057
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other