FDA.reportPublic FDA data

MAUDE MDR 9322143

MDR report key
9322143
Report number
3004608878-2019-01094
Event key
0
Event type
3
Date of event
2019-10-10
Date received
2019-11-14
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
MRS. VIVIAN NELSON
Address
311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
Phone
609-609-6099
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAYFIELD COMPOSITE SERIES SKULL CLAMP?COMPOSITE SERIES?INTEGRA LIFESCIENCES CORPORATION OH/USAHBLA3059R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-140

Event Narratives#

No narrative records found.