SKELITE UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-10-24 for SKELITE UNK * manufactured by Ebi, L.p..

Event Text Entries

[428727] Approximately fourteen months ago md implanted bone graft material for a fracture. At the present time the graft material has not resorbed and patient has developed a nonunion.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2242816-2005-00045
MDR Report Key643090
Report Source05
Date Received2005-10-24
Date of Report2005-10-20
Date of Event2004-04-21
Date Mfgr Received2005-09-22
Date Added to Maude2005-10-28
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 Location0
Manufacturer ContactBARRY SANDS, VP
Manufacturer Street100 INTERPACE PARKWAY
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal07054
Manufacturer Phone9732999300
Manufacturer G1BAXTER HEALTHCARE CORPORATION
Manufacturer Street1900 HIGHWAY, 201 NORTH
Manufacturer CityMOUNTAIN HOME AR 72653259
Manufacturer CountryUS
Manufacturer Postal Code72653 2597
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSKELITE
Generic NameBONE SUBSTITUTE
Product CodeLMN
Date Received2005-10-24
Model NumberUNK
Catalog Number*
Lot NumberUNK
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key632598
ManufacturerEBI, L.P.
Manufacturer Address* PARSIPPANY NJ * US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-10-24

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