FDA.reportPublic FDA data

MAUDE MDR 9391981

MDR report key
9391981
Report number
9610905-2019-00226
Event key
0
Event type
3
Date of event
2019-10-30
Date received
2019-11-29
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. JENNIFER DAMATO
Address
P.O. BOX 16369 JACKSONVILLE FL 32245 US
Phone
904-904-9046
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZYGOMA REDUCTION DEVICEBLADEKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KGLXH38-709-06-07KCBN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

IT WAS REPORTED THE INSTRUMENT BROKE DURING USE. A PORTION REMAINS IMPLANTED.

N

Patient 1

AN INVESTIGATION WAS PERFORMED USING A STEREO MICROSCOPE REVEALED TENSILE CRACKS. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS. THE COMPLAINT PERCENTAGE WAS CALCULATED, AND IT IS DETERMINED THAT THE COMPLAINT PERCENTAGE FALLS WITHIN THE DESIGN RISK LIMITS ADHERED TO AT KLM. DURING THE INVESTIGATION THE PRODUCT LOT NUMBER IDENTIFIED WAS REVIEWED IN THE DEVICE HISTORY RECORDS. THE DHR REVIEW SHOWED NO DISCREPANCIES OR ANOMALIES. THE INVESTIGATION RESULTS CONCLUDE THAT THE ROOT CAUSE FOR BREAKAGES WERE DUE TO STRUCTURAL FAILURE OF THE DEVICE DUE TO MECHANICAL OVERLOAD. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.