FDA.reportPublic FDA data

MAUDE MDR 9552146

MDR report key
9552146
Report number
0009613350-2020-00008
Event key
0
Event type
3
Date of event
2019-12-05
Date received
2020-01-06
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
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DYNESYS, PEDICLE SCREW + SET SCREW, 6.4X50DYNESYS, PEDICLE SCREW + SET SCREW, 6.4X50ZIMMER GMBHNQPN/A01.03764.0502942719R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-060

Event Narratives#

N

Patient 1

THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET?S REFERENCE NUMBER OF THIS FILE IS (B)(4).

D

Patient 1

EVENT HAPPENED DURING THE SURGERY WHEN THE SCREW THREAD COULD NOT BE LOCKED FOR FINAL LOCKING.