FDA.reportPublic FDA data

MAUDE MDR 9391647

MDR report key
9391647
Report number
3006524618-2019-00573
Event key
0
Event type
3
Date of event
2018-06-01
Date received
2019-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
HOLLY TOPPING
Address
7000 WEST WILLIAM CANNON DRIVE AUSTIN TX 78735 US
Phone
512-512-5123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
11.8MM Q-FIX ALL SUTURE ANCHORFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUEARTHROCARE CORP.MBI25-18001178587* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. O

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT AFTER AN ARTHROSCOPIC RIGHT SHOULDER BANKART REPAIR ON (B)(6) 2017, THE PATIENT HAD A RIGHT SHOULDER SUBLUXATION IN (B)(6) 2018. THE EVENT WAS TREATED WITH REST AND PHYSICAL THERAPY. THE OUTCOME IS ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.