MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199723645S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 12/08/2022

Event Type  Death  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, an unknown surgery was performed with the screw in question.After insertion of the screws, the patient¿s condition suddenly changed.The operation was cancelled in the middle of the procedure.After the surgery, it was confirmed by ct that there were no problems with the screw and the implants.No other medical intervention was required.There was no delay in surgery.The patient went into cardiac arrest and later died of heart failure.No further information is available.This report involves one expedium verse spine system fenestrated cortical fix polyaxial screw 6.0 x 45mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional device product codes: kwq, kqp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter name and address: (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 6.0 X 45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16111424
• MDR Text Key: 306783470
• Report Number: 1526439-2023-00016
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034443515
• UDI-Public: 10705034443515
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 199723645S
• Device Catalogue Number: 199723645S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE FEN SCR 6.0X45
• Patient Outcome(s): Death; Required Intervention