ALLPORT MASTOID SEARCHER 6 1/2" AU5680

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-29 for ALLPORT MASTOID SEARCHER 6 1/2" AU5680 manufactured by Allegiance Healthcare.

Event Text Entries

[22186847] The tip on the mastoid searcher broke off during a cervical spine procedure. The broken tip was not seen by the naked eye nor on x-ray.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423507-1998-00135
MDR Report Key165176
Report Source05,06
Date Received1998-04-29
Date of Report1998-04-29
Date of Event1998-02-13
Date Mfgr Received1998-04-01
Date Added to Maude1998-05-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameALLPORT MASTOID SEARCHER 6 1/2"
Generic NameINSTRUMENT
Product CodeJZC
Date Received1998-04-29
Returned To Mfg1998-04-14
Model NumberAU5680
Catalog NumberAU5680
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key160761
ManufacturerALLEGIANCE HEALTHCARE
Manufacturer Address1500 WAUKEGAN RD. MCGAW PARK IL 60085 US
Baseline Brand NameALLPORT MASTOID SEARCHER 61/2"
Baseline Generic NameINSTRUMENT
Baseline Model NoAU5680
Baseline Catalog NoAU5680
Baseline IDNA
Baseline Device FamilyINSTRUMENT
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-04-29

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