Model Number N/A |
Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Host-Tissue Reaction (1297); Cyst(s) (1800); Unspecified Infection (1930)
|
Event Date 05/29/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
An email was received from a surgeon stating a patient may have experienced an infection with chronic osteomyelitis after the scp procedure, which was performed approximately three years ago.X-ray images of the area were received and will be reviewed as a part of the investigation.Once additional information becomes available, a supplemental report will be submitted.
|
|
Event Description
|
Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiveing scp.
|
|
Manufacturer Narrative
|
The observations and pictures reported in this complaint were documented at the time of the revision surgery.The excised section pictured in the attached intraoperative photos was sent for pathology screening and confirmed to be infected through the pathology report.The infection appears to have been related to index procedure.The patient was successfully treated by removing the accufill and treating the infection with an antibiotic laden lattice and is progressing well.
|
|
Event Description
|
Patient appears to have developed an infection with chronic osteomyelitis as per the surgeon after receiving scp.
|
|
Search Alerts/Recalls
|