MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFEN XTAB 7X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186770445

Device Problem Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Additional procodes: kwp, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that during a transforaminal lumbar (tlif) procedure on (b)(6) 2019, the scrub nurse had difficulty loading the implant.The surgeon was about to implant but noticed the cage was not straight; the interface with inserter was not straight and in alignment with inserter.Another concorde bullet inserter was tried, but the cage was still not straight.Another implant had to be opened, which loaded correctly.Surgeon was getting s1 nerve root irritation with neuromonitoring so implanted and removed second implant.Had to get ct scan and navigate remaining screws.It was also reported that a viper prime screwdriver was not able to release screw and stylet was bent and had to be cut.There was a surgical delay of ten (10) minutes.Patient is recovering well.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown) this report is for a viper prime cfxfen xtab 7x45mm.This is report 2 of 6 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.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.

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation summary 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.Complainant part is not expected to be returned for manufacturer review/investigation.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: VIPER PRIME CFXFEN XTAB 7X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9504133
• MDR Text Key: 189067939
• Report Number: 1526439-2019-52746
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: 10705034509617
• Combination Product (y/n): N
• PMA/PMN Number: K170543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention