Model Number 629210S |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 08/05/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
|
|
Event Description
|
The customer presented a case where a long distal posterior lateral or distal lateral humeral variax elbow plate was used.They faced a complication which led to stop using the plates for complex distal humeral fractures.X-rays were shown where it looked like there was a loss of reduction after some time.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event, like x-rays, operation reports and as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Event Description
|
The customer presented a case where a long distal posterior lateral or distal lateral humeral variax elbow plate was used.They faced a complication which led to stop using the plates for complex distal humeral fractures.X-rays were shown where it looked like there was a loss of reduction after some time.
|
|
Search Alerts/Recalls
|