CARPAL POLY MEDIUM-STD 262300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-06-09 for CARPAL POLY MEDIUM-STD 262300 manufactured by Integra Lifesciences Corporation (integra-ohio).

Event Text Entries

[1404921] The distributor reported that a surgeon had noticed several cases where the carpal component of the uni 2 prosthesis had moved forward. The stem moves forward and the screws remain at the original position. Subsequently, the screws separate from the component and as a result, this misaligns the poly and leads to a luxation. In one reported case, the pt had no revision done. No lot or product identification reference numbers were provided by the reporter. Integra has requested additional info.
Patient Sequence No: 1, Text Type: D, B5


[8622839] The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3004608878-2010-00048
MDR Report Key1728846
Report Source01,08
Date Received2010-06-09
Date of Report2010-06-09
Date of Event2010-04-28
Date Mfgr Received2010-05-04
Date Added to Maude2011-04-27
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 ContactSUSAN SCOTT
Manufacturer Street311 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099363604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARPAL POLY MEDIUM-STD
Generic NameUNI2 TOTAL WRIST IMPLANT SYSTEM
Product CodeKWN
Date Received2010-06-09
Catalog Number262300
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION (INTEGRA-OHIO)
Manufacturer AddressPLAYA DEL REY CA 90293 US 90293


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-06-09

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