FDA.reportPublic FDA data

MAUDE MDR 8226418

MDR report key
8226418
Report number
3003853072-2019-00001
Event key
0
Event type
3
Date of event
2018-12-14
Date received
2019-01-08
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. DOROTHEE FLEURI
Address
23 PARVIS DES CHARTRONS CITE MONDIALE BORDEAUX, CEDEX US
Phone
335-335-3352
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 SPINEOWINASN2027-0-20055W61412Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0801. H; 2. R

Event Narratives#

N

Patient 1

UDI NUMBER: NI. 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 3003853072-2019-00002.

D

Patient 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS POST-OPERATIVE LOOSENING OF THE CONSTRUCT. DURING THE REVISION, THE NYLON BAND BROKE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.