MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Model Number 179712645 |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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, after an unknown procedure, the patient implants migrated posteriorly after a fall.The patient went to the clinic on may 8 and notified the surgeon about the fall while taking out the trash cans.Unknown date on the fall.The surgeon assumed that the cage migrated and had a ct scan done to confirm.According to the surgeon, the implants that are in the patient are not concorde lift but was possibly concorde bullet proti.There was no revision confirmation and patient symptoms are unknown.This complaint involves one (1) device.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Udi (b)(4).Device was not returned for evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|
|