MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40; SPINAL PEDICLE SCREW

Catalog Number	03.50.717
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 157314: (b)(4) items manufactured and released on 13-jan-2016.Expiration date: 2020-12-01.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.Additional implants involved: pedicle screw 03.50.716 reduction pedicle screw 6x35 (k153664) lot 156750: (b)(4) items manufactured and released on 23-nov-2015.Expiration date: 2020-11-07.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.Pedicle screw 03.50.712 reduction pedicle screw 5x45 (k153664) lot 1820241: (b)(4) items manufactured and released on 17-jul-2018.Expiration date: 2023-06-07.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.Clinical evaluation performed by medical affairs director: pedicle fracture detected few months after lumbar fusion surgery with pedicle screws and rods.No hint of a traumatic event that led to pedicle fracture.The clinical result was non-fusion at the index level.However, there is no indication in the report that the pedicle fracture may have been caused by a malfunctioning device.Weakening of the pedicle as a result of screw introduction is inevitable and cannot be regarded as a failure in the device performances.
Event or Problem Description
The patient came in complaining of pain due to a broken l5 vertebra pedicle.The cause of the broken pedicle is unknown, bone fusion was not achieved.No revision surgery has been scheduled at this time.

• Brand Name: PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40
• Common Device Name: SPINAL PEDICLE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649830
• Report Number: 3005180920-2019-00429
• Device Sequence Number: 16689915
• Product Code: NKB
• UDI-Device Identifier: 07630030846878
• UDI-Public: 07630030846878
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K153664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 12/01/2020
• Device Catalogue Number: 03.50.717
• Device Lot Number: 157314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: Required Intervention