PLEXUR M
Received Dec 29, 2010 · Event occurred Nov 1, 2010
Report 2246640-2010-00004 · MDR key 1947302
Device
Product problems
- Device Dislodged or Dislocated
Patient
Not reported
- Impaired Healing
Narrative
Additional Manufacturer Narrative
A LIST OF DETAILED QUESTIONS HAS BEEN FORWARDED TO THE SURGEON FOR F/U, AND OSTEOTECH'S MEDICAL DIRECTOR WILL BE CONTACTING THE SURGEON DIRECTLY IN AN EFFORT TO OBTAIN FURTHER INFO. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.
Description of Event or Problem
SURGEON STATES THAT AFTER HAVING IMPLANTED PLEXUR M IN A "SUPERFICIAL LOCATION" DURING A TIBIAL PROCEDURE, SOME OF THE GRAFT MATERIAL HAD "SPIT" FROM THE WOUND, RESULTING IN DELAYED WOUND HEALING AND REQUIRING RECLOSURE OF THE INCISION. NO ADDITIONAL DETAILS WERE PROVIDED. OSTEOTECH CONTACTED THE (B)(6) ON (B)(6) 2010, BUT THE (B)(6) WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO AND INDICATED THAT THE SURGEON WAS OUT OF TOWN AT THE TIME. SEVERAL SUBSEQUENT ATTEMPTS TO OBTAIN INFO HAVE BEEN UNSUCCESSFUL.