MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 179702000-12

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown single inner set screw.Part and lot numbers are unknown; udi number is unknown.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

It was reported that on (b)(6) 2019 surgeon revised a lumbar fusion construct (l2-l5), the set screw at the top of the construct (l2 left pedicle) had become dislodged from the tulip head and was adjacent to the construct on the left side.Surgeon observed "haloing" around the l2 pedicle screws bilaterally and intended to revise.The right side of the construct was securely intact, rods removed bilaterally and replaced the r side l2 cortical fix polyaxial screw 7 x 45mm with a half diameter larger expedium spine system si polyaxial screw 7.5mm x 45mm.Surgeon continued on to remove the hardware below (spineart romeo pedicle screw system at l3-5) and replaced the hardware with expedium 5.5 and proceeded to exposure, cannulate, and place bilateral pedicle screws at l1, then placed a 5.5.Ti rod from l1-4 (04.636.125 x 2), inserted new single inner set caps and successfully final tightened with the torque driver and counter torque without incident.Concomitant device reported: unknown rod (part # unknown, lot # unknown, quantity 1).This complaint involves five (5) devices.

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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

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.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9427978
• MDR Text Key: 185548832
• Report Number: 1526439-2019-52615
• Device Sequence Number: 1
• Product Code: NKB
• 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,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 179702000-12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR