MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM; MIS CANNULATED CORTICAL FIX X-TAB 6X45MM TI

Model Number	186760145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional pro-codes: kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that this was a spinal fusion applied to the 3rd left lumbar pedicle on (b)(6) 2019.After inserting a rod, the surgeon placed the setscrew (179702000) and tried to apply torque.But the torque did not become effective, and the setscrew and the cortical fix screw (186760145) broke.The procedure was completed with replacements less than 30-minute surgical delay.The surgeon x-rayed the patient postoperatively and confirmed that no fragment had been left in the body.No further information is available.This complaint involves three (3) devices.This report is 2 of 3 for (b)(4).

• Brand Name: VIPER SYSTEM
• Common Device Name: MIS CANNULATED CORTICAL FIX X-TAB 6X45MM TI
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9413741
• Report Number: 1526439-2019-52571
• Device Sequence Number: 2967026
• Product Code: NKB
• UDI-Device Identifier: 10705034465463
• UDI-Public: (01)10705034465463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186760145
• Device Catalogue Number: 186760145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/04/2019
• Patient Sequence Number: 1