Model Number PS10.0-50SJ235 |
Device Problems
Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Unspecified Infection (1930); Pain (1994); Osteomyelitis (4533)
|
Event Type
Injury
|
Manufacturer Narrative
|
The device has not been returned for evaluation.Root cause is unable to be determined at this time.The reported event has been addressed in the device labeling.
|
|
Event Description
|
Information was received via literature that a revision procedure was performed on an unknown date.As per the reporter, an hexapode external fixator was applied due to severe osteitis (infection) in the distal aspect of the tibia.The frame was removed after full consolidation of the distraction site and complete healing of the infection.
|
|
Manufacturer Narrative
|
Additional data: a4, b1, b5, b7, d8, h6.
|
|
Event Description
|
Additional information was received that the patient had osteomyelitis and reported pain during distraction.Additionally, it was reported that the implant was found to have corrosion.
|
|
Event Description
|
N/a.
|
|
Manufacturer Narrative
|
Additional data:.
|
|
Search Alerts/Recalls
|