FDA.reportPublic FDA data

MAUDE MDR 9908528

MDR report key
9908528
Report number
1219602-2020-00578
Event key
0
Event type
3
Date of event
2020-03-11
Date received
2020-03-31
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
1SUTUREFIX ULTRA AHR S 2 UB STR CB BLUFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUESMITH & NEPHEW, INC.MBI72203853722038532040748* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

(B)(6).

D

Patient 1

IT WAS REPORTED THAT DURING A BANKART REPAIR WHEN THE ANCHOR WAS PUT IN THE GLENOID, IT CAME OUT AFTER FIRST PULL CHECK, AN ADDITIONAL BONE HOLE WAS DRILLED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.