SURGICASE CONNECT, SURGICASE GUIDE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-06 for SURGICASE CONNECT, SURGICASE GUIDE manufactured by Materialise N.v..

Event Text Entries

[2904064] It was reported that the patient underwent a diaphyseal osteotomy utilizing the surgicase guide to predrill holes for the plate and to cut the wedge for the osteotomy. Difficulty with positioning of the guide resulted in 2 failed attempts to drill the holes for the plate in the right position. The 3rd attempt was successful and the plate was positioned in the planned position on the radius. The surgery on the ulna was performed without any problems. The 2 failed attempts resulted in a delay during surgery of approximately 35 min.
Patient Sequence No: 1, Text Type: D, B5


[10411304] Surgery was attended by a product engineer who provided extra measurements to allow extra verification of the guide fit. These were not used by the operating surgeon when positioning the guide on the radius. Based on the available information, the conclusion of the investigation shows that failure to follow instructions has caused the event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003998208-2012-00014
MDR Report Key2864401
Report Source07
Date Received2012-12-06
Date of Report2012-11-06
Date of Event2012-11-06
Date Mfgr Received2012-11-06
Device Manufacturer Date2012-10-01
Date Added to Maude2012-12-11
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 FDA0
Event Location0
Manufacturer ContactTHOMAS GULINCK
Manufacturer Street15 TECHNOLOGIELAAN
Manufacturer CityLEUVEN 3001
Manufacturer CountryBE
Manufacturer Postal3001
Manufacturer Phone6396666
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICASE CONNECT, SURGICASE GUIDE
Product CodePBF
Date Received2012-12-06
ID Number620913
Device Expiration Date2012-11-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMATERIALISE N.V.
Manufacturer AddressLEUVEN BE


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2012-12-06

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