MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW 6X45; SPINE PEDICLE SCREW

Catalog Number	03.50.018
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 03 jul 2019 lot 1820660: (b)(4) items manufactured and released on 13-sep-2018.Expiration date: 23-08-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed by r&d project manager of the items returned: the pedicle screw heads and the setscrews are damaged in the threaded area.The root cause of the damaging is probably due to the cross threading of the setscrew into the pedicle screw head.The assembling of the setscrew without any reduction device, that aim the setscrew centering, increase the risk of crossthreading.Additional information: in case of need, the usage of the setscrewdriver enhanced, ref.03.51.10.0218, can help during the insertion of the setscrew with centering of the pedicle screw head without the usage of a reduction device.Additional implants involved in the event, batch review performed on 03 jul 2019: pedicle screw 03.50.018 pedicle screw 6x45 (k121115) lot.165546 lot 165546: (b)(4) items manufactured and released on 28-nov-2016.Expiration date: 09-11-2021.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Pedicle screw 03.50.204 must combined setscrew h4-t27 - (4x) (k171758) lot.1920259 lot 1920259: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 10-03-2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.In this complaint two devices with the same lot were involved.
Event or Problem Description
Plif surgery was performed at l4-l5.The surgeon was not able to insert the set screws into the pedicle screw head at the left side of l4, so the surgeon disengaged the set screw, and discovered cross-threading on 2 set screws.Even though the surgeon replaced the new set screw, cross-threading reoccurred, so the surgeon had to replace the new pedicle screw.The same event also occurred at the right side of l4.Due to this event the surgery was prolonged about 20 minutes.

• Brand Name: PEDICLE SCREW 6X45
• Common Device Name: SPINE PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8764349
• Report Number: 3005180920-2019-00547
• Device Sequence Number: 19252406
• Product Code: KWP
• UDI-Device Identifier: 07630030834219
• UDI-Public: 07630030834219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2019

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 Expiration Date: 08/23/2023
• Device Catalogue Number: 03.50.018
• Device Lot Number: 1820660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/05/2019
• 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: 65 YR
• Patient Weight: 61