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

Model Number 179702000

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp;kwq;mnh;mni;osh.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(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

It was reported that on an unknown date, the patient underwent for a revision surgery.This revision surgery was to extend the construct to l2-5 and perform a tlif at l2/3 treating adjacent level degeneration.Rods and set screws were removed from previous construct but did not remove existing pedicle screws.She placed new pedicle screws at l2 under navigation with medtronic stealth.She proceeded to perform the discectomy and prepared the endplates of l2/3.The surgery and the patient outcome was unknown.This complaint involves six (6) number of devices.This report is for (1) single-inner setscrew.This is report 3 of 6 for (b)(4).Related product complaint: (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.H10: additional narrative: b5, d10: complainant part is not expected to be returned for manufacturer; review/investigation, d11; h11: corrected data: e1, e3, e4.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

It was further reported that two 5.5mm rods and six expedium set screws were removed to allow the construct to extend to l2 with uniform rods.Eight new set screws were implanted.Concomitant device reported: set screw (part unknown, lot unknown, quantity 4).

• Brand Name: SINGLE-INNER SETSCREW
• 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: 10649678
• MDR Text Key: 210428253
• Report Number: 1526439-2020-01906
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1
• Treatment: SINGLE-INNER SETSCREW.; UNKNOWN RODS.; UNKNOWN RODS.; UNKNOWN SCREWS.; UNKNOWN SCREWS.
• Patient Outcome(s): Required Intervention