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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA IMPLANT, METATARSAL, SIZE 1, R; NONE
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INTEGRA LIFESCIENCES CORPORATION OH/USA IMPLANT, METATARSAL, SIZE 1, R; NONE Back to Search Results
Catalog Number 012002
Device Problem Unstable (1667)
Patient Problem Osteolysis (2377)
Event Date 07/17/2014
Event Type  Injury  
Event Description
It was reported a kgti great toe metatarsal implant was implanted in 2008.In 2014 "serious instability and bone erosion was noted.On (b)(6) 2014, the implant was removed".Numerous request for additional clinical information were sent to the surgeon.
 
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.
 
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Brand Name
IMPLANT, METATARSAL, SIZE 1, R
Type of Device
NONE
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORPORATION OH/USA
cincinnati OH 45227
Manufacturer Contact
carmen finkelstein
315 enterprise drive
plainsboro, NJ 08536
6099362341
MDR Report Key4067996
MDR Text Key4897547
Report Number3004608878-2014-00133
Device Sequence Number1
Product Code LZJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number012002
Device Lot Number16241-21
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PHALANGEAL COMPONENT SIZE 1, PRODUCT ID: 01-2012,; LOT NUMBER M058-12
Patient Outcome(s) Required Intervention;
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