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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - ATTACHMENTS: MIS VIPER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNK - ATTACHMENTS: MIS VIPER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK - ATTACHMENTS: MIS VIPER
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 attachment/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 attachment.This is report 26 of 26 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.
 
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Brand Name
UNK - ATTACHMENTS: MIS VIPER
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle MA 02400
SZ  02400
MDR Report Key12025494
MDR Text Key257119072
Report Number1526439-2021-01254
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK - ATTACHMENTS: MIS VIPER
Was Device Available for Evaluation? No
Date Manufacturer Received09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN ATTACHMENTS; UNKNOWN ATTACHMENTS; UNKNOWN BIOMATERIAL - CEMENT; UNKNOWN BIOMATERIAL - CEMENT; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICES; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN SCREWS
Patient Outcome(s) Death; Required Intervention;
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