SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE 37503

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-07-29 for SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE 37503 manufactured by Dentsply Implants N.v..

Event Text Entries

[21331615] In this case, a customer planned to place three implants by the support of a surgiguide. Intraoperatively, the guide broke between the planned implants in region #13 and #14, when the dentist used the punch to remove soft tissue. Therefore, the dentist aborted the surgical treatment.
Patient Sequence No: 1, Text Type: D, B5


[21702369] Therefore, because treatment could not be completed, this event is reportable per 21 cfr part 803. The guide fracture was caused by a combination of an inaccurate plaster model and possible removal of too much material during production process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007362683-2015-00010
MDR Report Key4961236
Report Source01,05
Date Received2015-07-29
Date of Report2015-03-27
Date of Event2015-02-04
Date Mfgr Received2015-03-27
Date Added to Maude2015-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactHELEN LEWIS
Manufacturer Street221 W.PHILADELPHIA ST., STE 60 SUSQUEHANNA COMMERCE CENTER W.
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178457511
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE
Generic NameVARIOUS, EBG, LLZ, DZE
Product CodeEBG
Date Received2015-07-29
Returned To Mfg2015-04-17
Catalog Number37503
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDENTSPLY IMPLANTS N.V.
Manufacturer AddressHASSELT LIMBURG BE


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-07-29

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