FDA.reportPublic FDA data

MAUDE MDR 8509980

MDR report key
8509980
Report number
0008010177-2019-00015
Event key
0
Event type
3
Date of event
2019-03-12
Date received
2019-04-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. ELKIA ARENS
Address
BOETZINGERSTR. 41 FREIBURG D-791
Phone
761-761-7614
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PEEK CUSTOMIZED CRANIAL IMPLANT KIT, LIMPLANTSTRYKER LEIBINGER FREIBURGGWO78-100301808081002R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-120

Event Narratives#

N

Patient 1

THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE FACILITY AT THEIR LOCATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. THE PRODUCT WAS DISCARDED BY THE FACILITY AT THEIR LOCATION.

D

Patient 1

IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT AFTER IMPLANTING A PEEK IMPLANT, THE PATIENT ACQUIRED AN INFECTION AND THE DEVICE WAS REMOVED. THE FACILITY DISCARDED THE FLAP IN THE OPERATING ROOM AND REVISION SURGERY IS PLANNED.