Model Number 1192.0020 |
Device Problems
Fracture (1260); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 05/19/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The devices were not available for evaluation as they remain in the patient.Imaging provided shows a displaced locking cap and fractured screw shank.The exact cause of the reported issue could not be determined.
|
|
Event Description
|
It was reported that a locking cap popped off and a screw came loose and fractured post-operatively.
|
|
Manufacturer Narrative
|
Evaluation of the hardware received shows wear and markings consistent with normal use.Imaging provided shows a displaced locking cap and fractured screw shank.It was determined during the surgery that the patient had significant osteoporosis which may have been a contributing factor.The exact cause of the reported issue could not be determined.
|
|
Event Description
|
It was reported that a revision surgery was completed due to a locking cap popping off, and a screw loosening and fracture post-operatively.
|
|
Search Alerts/Recalls
|