INTERGRO DBM PUTTY
Received Oct 21, 2013 · Event occurred Apr 22, 2013
Report 0002242816-2013-00128 · MDR key 3421327
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Wound Dehiscence
Narrative
Description of Event or Problem
IT WAS REPORTED, PATIENT RETAINED SMALL AMOUNT OF CANCELLOUS BONE IN SOFT TISSUE CAUSING DEHISCENCE. THE DOCTOR PERFORMED INCISION AND DRAINAGE TO REMOVE THE CANCELLOUS CHIPS FROM THE WOUND SITE. THE WOUND COMPLETED HEALED 2 MONTH AFTERWARDS.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE COMPLETED.A REVIEW OF THE MANUFACTURING RECORD REVEALS THAT THE GRAFT PASSED THE LIMULUS AMEBOCYTE LYSATE (LAL) GEL-CLOT ASSAY AND THE SEROLOGY REPORTS FROM THE TISSUE BANK REVEALED THAT THE DONOR WAS FOUND TO BE ELIGIBLE FOR TISSUE DONATION BY TESTING PERFORMED AT A (B)(4) LABORATORY.CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.