FDA.reportPublic FDA data

MAUDE MDR 6576974

MDR report key
6576974
Report number
3012429393-2017-00001
Event key
0
Event type
3
Date of event
2017-04-24
Date received
2017-05-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. BRYAN BROSSEAU
Address
7842 HICKORY FLAT HWY SUITE B WOODSTOCK GA 30188 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CERAFIX? DURA SUBSTITUTEDURA SUBSTITUTEACERA SURGICALGXQC1 - 2X212R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-1801. R

Event Narratives#

N

Patient 1

THE INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. ANY ADDITIONAL INFORMATION OBTAINED DURING THE INVESTIGATION AND THE RESULTS OF THE INVESTIGATION WILL BE REPORTED IN A FOLLOW-UP REPORT.

D

Patient 1

ACCORDING TO THE INFORMATION PROVIDED BY THE COMPLAINANT, THE SURGEON PERFORMED A CRANIOTOMY PROCEDURE ON (B)(6) 2017 IN WHICH CERAFIX? DURA SUBSTITUTE WAS UTILIZED TO CLOSE A DURAL DEFECT IN CONJUNCTION WITH BOTH ADHERUS AND TISSEEL DURAL SEALANTS USING A "SANDWICH" TECHNIQUE. THE COMBINED USE OF THESE PRODUCTS IS NOT AN INDICATED USE OF CERAFIX AND ACERA DOES NOT PROMOTE OR RECOMMEND THIS APPLICATION TECHNIQUE. THE CERAFIX PRODUCT USED IN THIS CASE IS INDICATED FOR THE REPAIR OF DURAL DEFECTS AND IS TO BE USED WITH TENSIONLESS SUTURES. THE ORIGINAL PROCEDURE ON (B)(6) 2017 UTILIZED A RETRO-SIGMOIDAL APPROACH TO THE BRAINSTEM, RESULTING IN A DURAL DEFECT THAT THE SURGEON DESCRIBED AS "TOUGH TO CLOSE". THE SURGEON UTILIZED A 2X2" PIECE OF CERAFIX TO REPAIR THE DURAL DEFECT, WHICH HE CUT TO FIT THE DEFECT AND PLACED ON THE DEFECT IN AN ONLAY FASHION. DUE TO THE LACK OF NATIVE DURA THE CERAFIX MATERIAL DIRECTLY APPROXIMATED THE BONY EDGES OF THE CRANIOTOMY. THE SURGEON THEN APPLIED ADHERUS DURAL SEALANT OVER THE CERAFIX MATERIAL, FOLLOWED BY A LAYER OF TISSEEL DURAL SEALANT OVER THE ADHERUS SEALANT, IN A "SANDWICH" TECHNIQUE. IT IS ALSO POSSIBLE THAT GELFOAM WAS APPLIED DURING THIS PROCEDURE. THE SURGEON THEN CLOSED THE OVERLYING MUSCULATURE AND FASCIA OVER THE REPAIR SITE. ON (B)(6) 2017 THE SURGEON BROUGHT THE PATIENT BACK FOR RE-OPERATION DUE TO A MINOR CSF LEAK AT THE OPERATIVE SITE, A FINDING WHICH THE SURGEON DESCRIBED AS "NOT UNUSUAL" FOR THIS TYPE OF EXPOSURE. UPON RE-OPERATION, THE SURGEON EXPOSED THE SURGICAL SITE AND NOTED THAT THE CERAFIX MATERIAL WAS EMBEDDED IN THE GREEN ADHERUS SEALANT MATERIAL AND APPEARED "FLAKY". SPECIFICALLY, THE SURGEON NOTED THAT THE CERAFIX MATERIAL WAS PRESENT IN MANY SMALL PIECES, ALL EMBEDDED WITHIN THE ADHERUS SEALANT, AND THAT THE CERAFIX / ADHERUS CONSTRUCT WAS NOT "HOLDING". NO SIGN OF INFECTION WAS NOTED. THE SURGEON THEN REMOVED THE CERAFIX / ADHERUS MATERIAL AND PERFORMED A SECONDARY DURAL REPAIR UTILIZING FASCIA LATA, TISSEEL DURAL SEALANT, GELFOAM, AND PMMA CEMENT. THE PATIENT UNDERWENT A REPEATED SURGICAL PROCEDURE BUT OTHERWISE DID NOT EXPERIENCE ANY INJURY ATTRIBUTED TO THE PRODUCT OR PROCEDURE. PRIOR TO THIS CASE THE SURGEON NOTED THAT HE HAS UTILIZED CERAFIX "VERY SUCCESSFULLY" ON MULTIPLE OCCASIONS.