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

Model Number	186770445
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Additional 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.
Additional 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9504133
• Report Number: 1526439-2019-52746
• Device Sequence Number: 16496390
• Product Code: NKB
• UDI-Device Identifier: 10705034509617
• UDI-Public: 10705034509617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170543
• 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,Followup,Followup
• Report Date (Section B): 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186770445
• Device Catalogue Number: 186770445
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 02/10/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 12/20/2019; 02/19/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention