MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
|
Back to Search Results |
|
Model Number 179702000 |
Device Problem
Device Slipped (1584)
|
Patient Problem
Failure of Implant (1924)
|
Event Type
Injury
|
Manufacturer Narrative
|
Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number: (b)(6).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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date six (6) set screws were loose in the patient ten (10) dats after scoliosis surgery.There is no further information available.This report is for one (1) single-inner setscrew.This is report 6 of 6 for (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.H3, h4, h6- the single inner setscrews (p/n: 179702000, lot number: 278172) was received at us cq.Upon visual inspection, the device was found intact.The provided x-ray show the set screw was migrated.The complaint condition was confirmed as implant was shifted after implantation.There is no indication that a design or manufacturing issue has caused the complaint condition.It is possible that the the implant was not tightened properly during implantation.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.Device history lot = the dhr of product code: 179702000, lot : 278172, was electronically reviewed and no non-conformances.Were observed during the manufacturing process.The product was released on: 06.04.2020.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.
|
|
Event Description
|
It was reported the revision procedure occurred on (b)(6) 2020.
|
|
Search Alerts/Recalls
|
|
|