FDA.reportPublic FDA data

MAUDE MDR 5735393

MDR report key
5735393
Report number
0001032347-2016-00303
Event key
0
Event type
3
Date received
2016-06-20
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. MICHELLE COLE
Address
1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US
Phone
904-904-9047
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKNOWN STERNALOCK BLUE SCREWSBONE SCREWBIOMET MICROFIXATIONHWDN/AUNKNOWN SL BLU SCREWSUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-2001. H; 2. R

Event Narratives#

N

Patient 1

THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT 1 OF 2 IS REPORTED ON MFR #0001032347-2016-00302.

D

Patient 1

IT IS REPORTED THAT A REVISION SURGERY IS PLANNED TO REMOVE A BROKEN STERNALOCK BLUE PLATE AND CORRESPONDING SCREW. THE PLATE AND SCREW CURRENTLY REMAIN IN THE PATIENT'S BODY.