FDA.reportPublic FDA data

MAUDE MDR 7507719

MDR report key
7507719
Report number
2027754-2018-00020
Event key
0
Event type
3
Date of event
2018-04-17
Date received
2018-05-11
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
MRS. LATOIA PHILLIPS
Address
3885 ARAPAHO ROAD ADDISON TX 75001 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSTEOVATIONOSTEOVATION RMX 10CCOSTEOMEDGXP390-600216120701R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-1101. R

Event Narratives#

D

Patient 1

ON (B)(6) 2018, OSTEOMED WAS NOTIFIED OF AN INCIDENT CONCERNING AN ABSCESS THAT OCCURRED IN A PATIENT WITH OSTEOMED IMPLANTS. PER THE SALES REPRESENTATIVE, THE PATIENT RECEIVED MULTIPLE IMPLANTS AS PART OF A LEFORT I OSTEOTOMY PROCEDURE PERFORMED ON (B)(6) 2018. ALMOST ONE (1) MONTH FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED RIGHT CHEEK SWELLING. ON (B)(6) 2018, THE AREA OF THE SURGERY WAS OPENED TO LOCATE THE ABSCESS. THE AREA WAS ALLOWED TO DRAIN. FOLLOWING DRAINAGE, THE AREA WAS IRRIGATED. A CULTURE WAS TAKEN AND SENT FOR TESTING. THE RESULTS DID NOT IDENTIFY ANY ORGANISMS.