Model Number 04.511.225.01 |
Device Problem
Unintended Movement (3026)
|
Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924)
|
Event Date 01/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event: unknown date.Device evaluated by mfr, manufacture date: 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
|
It was reported that on (b)(6) 2019, the patient experienced nonunion of the maxilla.There were probably 18 screws loosen.Maxilla was re-plated, nonunion was cleaned out, debrided back to the bleeding bone.The surgeon had to move the maxilla forward too far which put under stress on the hardware.The original date of implant was on (b)(6) 2019.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.Concomitant device report: trumatch 3d plate (part # sd980.014 lot # unknown, quantity 1).This report is for one (1) 1.85mm ti matrix screw self-drilling/5mm.This is report 6 of 9 for (b)(4).This complaint is a continuation from the linked complaint (b)(4) for the additional 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.Event occurred on an unknown date in 2019, not (b)(6) 2019.Facility information captured, and contact updated to reflect physician.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.
|
|
Search Alerts/Recalls
|
|