MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 186715000

Device Problems Device Slipped (1584); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni, osh.Date of implantation is an unknown date in 2018.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that patient underwent revision surgery following a scoliosis fixation performed in 2018 due to screw pull-out.The procedure was performed by the same surgeon in the same hospital.During this revision, the surgeon reported that previously placed innies were found to be loose in some screws.The procedure was completed successfully with no delay.This report is for a viper set screw.This is report 1 of 2 for (b)(4).Additional reports are captured under (b)(4).

Manufacturer Narrative

Product complaint (b)(4).Depuy synthese 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.D10: additional concomitant device reported.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 #
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> pc-(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.H10 additional narrative: d4: updated e1: phone# +41(79)6419582 h3, h6: investigation summary investigation flow: functional visual inspection: mis single inner setscw (part# 186715000, lot# 192997, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device shows slight deformation of the bottom surface of the screw.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional test: complete functional testing of the received device cannot be performed at cq.The inner set screw received was screwed into all the polyaxial screws received and removed without any issues.Can the complaint be replicated with the returned device(s)? unable to perform note: the x-ray images shows that the inner set screws were backed out from their original position.Dimensional inspection (micrometer: om803): dimensional inspection of the received set screw was performed at cq.The external threaded diameter of the set screw was intended to be measuring from 8.725mm to 8.775mm and it was measured to be 8.753mm which is within specification as per the drawing 1797-02-001 rev.A.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? yes investigation conclusion: the complaint is being confirmed for mis single inner setscw (part# 186715000, lot# 192997) as the inner set screws were backed out from their original position.A definitive root cause could not be identified for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot the dhr of product code: 186715000 lot : 192997 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 07.05.2018 qty: 442 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: MIS SINGLE INNER SETSCW
• 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: 11404782
• MDR Text Key: 234451716
• Report Number: 1526439-2021-00379
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: (01)10705034121192
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715000
• Device Catalogue Number: 186715000
• Device Lot Number: 192997
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Patient Sequence Number: 1
• Treatment: MIS CANN POLY SCW 5X35MM,TI; MIS CANN POLY SCW 5X35MM,TI; MIS CANN POLY SCW 6X40MM,TI; MIS CANN POLY SCW 6X40MM,TI; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS SINGLE INNER SETSCW; MIS CANN POLY SCW 5X35MM,TI; MIS CANN POLY SCW 6X40MM,TI; MIS SINGLE INNER SETSCW
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Weight: 60