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

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 setscrew.Part and lot numbers are unknown; udi number is unknown.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

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 7x45mm with a half diameter larger expedium spine system si polyaxial screw 7.5mmx45mm.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.This is 2 of 5 for report (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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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).Udi: (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.Upon visual inspection, it was observed that there were scratches and the etch on the device was illegible which has no impact on the functionality of the device.No other issues were identified with the returned components of the device.The functional test was performed on the returned devices.The set screw was assembled without issue.The complaint condition is un-confirmed for the single-inner set screw (p/n:179702000-12)as the device was assembled with 5.5 ti cort fix 7x45 device with no issues.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9427924
• MDR Text Key: 188058780
• Report Number: 1526439-2019-52612
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR