ZYGOMA REDUCTION DEVICE 38-709-06-07

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for ZYGOMA REDUCTION DEVICE 38-709-06-07 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.

Event Text Entries

[168463924] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[168463925] It was reported the instrument broke during use. A portion remains implanted.
Patient Sequence No: 1, Text Type: D, B5


[184390149] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610905-2019-00226
MDR Report Key9391981
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-10-30
Date of Event2019-10-30
Date Facility Aware2019-10-30
Report Date2019-10-30
Date Reported to Mfgr2019-10-30
Date Mfgr Received2019-10-30
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNIFER DAMATO
Manufacturer StreetP.O. BOX 16369
Manufacturer CityJACKSONVILLE FL 32245
Manufacturer CountryUS
Manufacturer Postal32245
Manufacturer Phone9046417746
Manufacturer G1KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
Manufacturer StreetKOLBINGER STRASSE 10
Manufacturer CityMUEHLHEIM/DONAU, 78570
Manufacturer CountryGM
Manufacturer Postal Code78570
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZYGOMA REDUCTION DEVICE
Generic NameBLADE
Product CodeLXH
Date Received2019-11-29
Model Number38-709-06-07
Lot NumberKCB
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
Manufacturer AddressKOLBINGER STRASSE 10 MUEHLHEIM/DONAU, 78570 GM 78570


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-29

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