Catalog Number W31G |
Device Problems
Failure To Adhere Or Bond (1031); Appropriate Term/Code Not Available (3191)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Blood Loss (2597); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Date sent to the fda: 12/03/2015.(b)(4).Conclusion: the representative sample was received for evaluation.Visual and functional examinations revealed no defects and the ball of wax was spread on the folder without problems.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
|
|
Event Description
|
It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used.It was also reported that the use of bone wax resulted in post- operative brain bleeds requiring additional surgery.Additional information has been requested.
|
|
Manufacturer Narrative
|
It was reported that the patient underwent a craniotomy procedure on unknown date and bone wax was used.The patient underwent re-operation to repair a csf leak.The surgeon opined the re-operation was required due to the sub-optimal adherence of the wax to the bone and its failure to stay in place allowing the csf leak to occur.At the time of re-operation the previously placed bone wax was dry, brittle, loosely attached to the bone.The patient is doing well currently.(b)(4).
|
|
Manufacturer Narrative
|
Corrected narrative: it was reported that the patient underwent craniotomy on an unknown date and bone wax was used.It was reported by the facility that the bone wax consistency was more brittle, seemed dry and was less sticky to the bone.There were no adverse patient consequences reported.(b)(4).
|
|
Search Alerts/Recalls
|