FDA.reportPublic FDA data

MAUDE MDR 5404280

MDR report key
5404280
Report number
3003875359-2016-10067
Event key
0
Event type
3
Date of event
2016-01-15
Date received
2016-02-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LINDA PLEWS
Address
1302 WRIGHTS 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
1TRIAL SPACER HANDLEHANDLE, SCALPELSYNTHES HAGENDORFGDZ397.0898918794R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-02-020

Event Narratives#

N

Patient 1

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION / INVESTIGATION, BUT HAS YET TO BE RECEIVED.DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 04. APR. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

D

Patient 1

IT WAS REPORTED THE SURGEON WAS PERFORMING AN ANTERIOR LUMBAR INTERBODY FUSION AT L4-S1 WHEN THE TRIAL HANDLE/SPINDLE BROKE. WHILE USING THE FRA SPACER SYSTEM, THE TRIAL HANDLE/SPINDLE BROKE INSIDE THE TRIAL AND THE TRIAL WAS STUCK INSIDE THE DISC SPACE. THE TRIAL WAS REMOVED WITH KOCHER AND SURGEON HAD TO DRILL THE BONE SLIGHTLY. THERE WAS A 5 MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. THIS IS 1 OF 1 FOR (B)(4).