FDA.reportPublic FDA data

MAUDE MDR 6421696

MDR report key
6421696
Report number
3005168462-2017-00001
Event key
0
Event type
3
Date of event
2017-02-23
Date received
2017-03-21
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
MR. CASEY MING
Address
600 CRUISER LANE BELGRADE MT 59714 US
Phone
406-406-4063
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSTEOSELECTFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)BACTERIN INTERNATIONAL, INC.MBP359100B110246-DBMR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-210

Event Narratives#

N

Patient 1

THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS. DEVICE IMPLANTED, NOT RETURNED FOR EVAL.

D

Patient 1

THE COMPANY WAS NOTIFIED ON 02/24/2017 THAT AN EXPIRED PRODUCT WAS IMPLANTED INTO A PATIENT ON (B)(6) 2017. THE PRODUCT'S EXPIRATION DATE WAS 02/08/2017. THE HOSPITAL WAS NOTIFIED BY THE COMPANY ON 02/20/2017 THAT THEY HAD AN EXPIRED GRAFT IN INVENTORY. SUBSEQUENT COMMUNICATION WITH THE HOSPITAL ON 03/10/2017, REVEALED THAT AN EMPLOYEE ABSENCE COULD HAVE CONTRIBUTED TO THE INCIDENT DESPITE THE NOTIFICATION FROM THE COMPANY. PATIENT DISCHARGED ON (B)(6) 2017 WITH NO KNOWN COMPLICATIONS.