FDA.reportPublic FDA data

MAUDE MDR 7479391

MDR report key
7479391
Report number
8030965-2018-53493
Event key
0
Event type
3
Date received
2018-05-02
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. MICHAEL COTE
Address
1302 WRIGHT LANE EAST WEST CHESTER PA 19380 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DISPENSER, CEMENTOBERDORF SYNTHES PRODUKTIONS GMBHKIH* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-0201. R

Event Narratives#

N

Patient 1

PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. EVENT YEAR REPORTED AS 2018; EXACT DATE IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICE. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER?S PHONE NUMBER IS NOT PROVIDED FOR REPORTING. (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR CEMENT DELIVERY DEVICE IS NOT PROVIDED. (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED: THE CEMENT HARDENED TOO QUICKLY PREVENTING THE INJECTION DEVICE FROM BEING REMOVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AUGMENTATION OF TFN-ADVANCED? PROXIMAL FEMORAL NAILING SYSTEM (TFNA), THE TRAUMACEM CEMENT HARDENED QUITE FAST. BECAUSE OF THIS IT WAS IMPOSSIBLE TO REMOVE THE CEMENT CANNULA. IT BROKE AND A PART OF THE CANNULA REMAINED IN THE BLADE. NO OTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT DELIVERY DEVICE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).