FDA.reportPublic FDA data

MAUDE MDR 8416421

MDR report key
8416421
Report number
3011386779-2019-00021
Event key
0
Event type
3
Date of event
2019-02-18
Date received
2019-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR NIKLAS HOFVERBERG
Address
KROKSLATTS FABRIKER 50 MOLNDAL, VASTRA GOTALAND 43137 SW
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXOR IIAXOR IIINTEGRUM ABPJY12881288U87002-3-12Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-1301. O

Event Narratives#

D

Patient 1

PROBLEMS WITH ATTACHING THE AXOR II TO THE ABUTMENT. AXOR DID NOT CLAMP PROPERLY. PROSTHESIS DETACHED AND PATIENT FELL.