DISTRACTION 50-347-07-09

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 2020-02-19 for DISTRACTION 50-347-07-09 manufactured by Karl Leibinger Medizintechnik Gmbh & Co. Kg.

Event Text Entries

[184296306] (b)(4). Reference exemption number e2017029. An investigation was performed on the basis of complaint statistics as no device was returned for evaluation. The failure root cause cannot be determined due to the device not being returned. Based on the information provided the most likely root cause is patient condition due to possible early healing of the osteotomy. 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


[184296307] It was reported that the screws pulled out during activation of the distractor possible due to early healing of the osteotomy. The screws were removed and replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610905-2020-00009
MDR Report Key9726392
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-19
Date of Report2020-02-07
Date of Event2020-02-07
Date Facility Aware2020-02-07
Report Date2020-02-07
Date Reported to Mfgr2020-02-07
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-19
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
Manufacturer CountryUS
Manufacturer Phone6417746
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 NameDISTRACTION
Generic NameDISTRACTION
Product CodeMQN
Date Received2020-02-19
Model Number50-347-07-09
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
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 2020-02-19

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