Catalog Number UNK_WWA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Implant Pain (4561)
|
Event Date 10/25/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
|
|
Event Description
|
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to ankle pain.
|
|
Event Description
|
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to ankle pain.
|
|
Manufacturer Narrative
|
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.An assessment could not be made due to the poor quality of the ct scans.More detailed information about the complaint event 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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|
|
Search Alerts/Recalls
|