INTERPHLEX IPJ 360-2808

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 2007-05-25 for INTERPHLEX IPJ 360-2808 manufactured by Osteomed L.p..

Event Text Entries

[614909] A male with hx of dislocated toe and hammertoe. Dr performed implant in 2004. In 2007, implant was removed because it had broken. Pt currently doing fine - not in pain. At time of surgery surgeon loosened tendons as required. No history of pt. Trauma to toe. Pt hammertoe reoccurred before explant - possibly due to pt's natural anatomy or the fact that more of a tendon lengthening/capsulotomy was needed at initial implantation.
Patient Sequence No: 1, Text Type: D, B5


[7959743] During telephone call with dr. He stated that "post op the toe dislocated and took the stem with it, breaking implant. "
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2027754-2007-00005
MDR Report Key855604
Report Source05
Date Received2007-05-25
Date of Report2007-05-25
Date of Event2007-03-09
Date Added to Maude2007-06-01
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 Street3885 ARAPAHO RD.
Manufacturer CityADDISON TX 75001
Manufacturer CountryUS
Manufacturer Postal75001
Manufacturer Phone9726774787
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTERPHLEX IPJ
Generic NameINTERPHALANGEAL SPACER
Product CodeLZJ
Date Received2007-05-25
Returned To Mfg2007-04-30
Model Number360-2808
Catalog Number360-2808
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key841801
ManufacturerOSTEOMED L.P.
Manufacturer AddressADDISON TX 75001 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-05-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.