FDA.reportPublic FDA data

MAUDE MDR 7756370

MDR report key
7756370
Report number
3003853072-2018-00058
Event key
0
Event type
3
Date of event
2018-06-19
Date received
2018-08-07
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. TERESA GEORGE
Address
10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US
Phone
303-303-3034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPINAL IMPLANT FOR OSTEOSYNTHESIS (TI) DIAMETER 5.5MMUNIVERSAL CLAMP SPINAL FIXATION SYSTEMZIMMER SPINEOWINASN2027-0-20055W55664R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-0701. O

Event Narratives#

N

Patient 1

WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. REFERENCE REPORT 3003853072-2018-00059.

D

Patient 1

IT WAS REPORTED THAT A VERTEBRAL BODY FRACTURED DURING SURGERY WHILE INSTALLING TWO SPINAL IMPLANT DEVICES. NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS IS REPORT ONE OF TWO FOR THIS EVENT.