MAUDE MDR 8737698

MDR report key
8737698
Report number
3009196021-2019-00006
Event key
0
Event type
3
Date of event
2018-07-19
Date received
2019-06-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. ESTELLE ANUWE
Address
501 S. 2ND AVE. SUITE A1000 DALLAS TX 75226 US
Phone
214-214-2144
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCUSHAPEPEEK PATIENT-SPECIFIC IMPLANTMEDCADGXNACSL-003182624 BROR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-06-2601. R

Event Narratives#

No narrative records found.