MDR event
Received Jul 12, 2013 · Event occurred Jun 13, 2013
Report 0001825034-2013-02664 · MDR key 3223789
Device
Product problems
- Difficult to Remove
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIAL PLATING PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A PLATE REMOVAL PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO REMOVE ONE OF THE SCREWS; IT IS UNKNOWN WHICH SCREW WAS NOT REMOVED. THE PATIENT RETAINED THE PLATE AS WELL AS THE SCREW. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Additional Manufacturer Narrative
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A SURGICAL DELAY MAY HAVE OCCURRED; IT IS ALSO UNKNOWN WHICH SCREW THE SURGEON WAS UNABLE TO REMOVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY. IT IS UNKNOWN WHICH OF THE FOLLOWING PRODUCTS WAS RETAINED BY THE PATIENT: (B)(4).