MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK SCREWS

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

Patient Problem Cardiac Arrest (1762)

Event Date 05/21/2021

Event Type  Death  

Manufacturer Narrative

This report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.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.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.

Event Description

Device report from the (b)(6) reports an event as follows: it was reported that patient underwent a 4 level stabilisation of ankylosing spondylitis using viper cortical fix fenestrated screws and confidence cement on (b)(6) 2021.Toward the end of the case the anaesthetist notified the surgeon that the procedure had to be halted immediately and the patient passed away on the table soon after.All 8 set screws had been placed, but one not tightened in the final rush to remove instrumentation at the end of the case.The surgeon used all expedium fenestrated screws but still said bone was not good, so elected to augment with confidence cement.Two boxes of cement were injected into 3 levels.A third box was opened but the anaesthetist said there was a change in bp, so it was not used.The first rod went in ok and tightened up well; used reducer well.During second rod insertion, patient became very unwell.Patient was not turned to try recovery.The following day, the sales consultant noticed 8 nonsterile guide wires in a cupboard.They told surgeon that there was a possibility that there could be none on the set.The facility operates a ¿only open sets when patient on table¿ procedure.When the kits were opened, there were no guide wires and at least 20 screws missing.All viper sets were opened to see if guide wires were in them.After 20 minutes they found k2m 1.4mm guide wires which worked well.There were no set screws on the viper set.The verse fenestrated screws had 5mm and 6mm screws missing.This report is for an unknown screw.This is report 18 of 26 for (b)(4).

• Brand Name: UNKNOWN SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12025047
• MDR Text Key: 257113307
• Report Number: 1526439-2021-01246
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SCREWS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2021
• 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
• Patient Outcome(s): Death; Required Intervention