Model Number PS10.0-50D235 |
Device Problems
Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Osteolysis (2377)
|
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 the patient had localized osteolysis level with the nail's telescopic junction which is clearly atypical and potentially implant-related.Additionally, appositional bone growth was noted at the level of the distal locking bolts.Residual localized osteolysis was seen after removal of the nail.
|
|
Event Description
|
Additional information was provided that the patient had lytic-hypertrophic osteolysis and reported pain during distraction and consolidation.Additionally, it was reported that the implant had a corrosive stain.
|
|
Manufacturer Narrative
|
Corrected data: b2.Additional data: a4, b1, b5, b7, d8, h6.
|
|
Manufacturer Narrative
|
Additional data.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|