FDA.reportPublic FDA data

MAUDE MDR 5989422

MDR report key
5989422
Report number
1030489-2016-02722
Event key
0
Event type
3
Date received
2016-09-30
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
GREG ANGLIN
Address
1800 PYRAMID PLACE MEMPHIS TN 38132 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SHILLA GROWTH GUIDANCE SYSTEMMEDTRONIC SOFAMOR DANEK USA, INCPGMNA7675535CA14F041N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-3001. R

Event Narratives#

N

Patient 1

(B)(4) (INTERVENTION REQUIRED). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, LOOSENING OF SCREW AT L3 AND L4 OF LEFT SIDE WAS FOUND BY X-RAY. THERE HAD BEEN NO SYMPTOM AT ALL IN THE PATIENT BUT RE-OPERATION IS PLANNED ON (B)(6) 2016.

N

Patient 1

A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.