PINS/WIRES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2012-06-04 for PINS/WIRES manufactured by .

Event Text Entries

[2785897] The manager, market development, trauma reported surgeon submitted a presentation, "nonunion" failure of a fracture to heal, failure of advancing healing for approval. It showcases ten patients, various collected cases on the topic of nonunions. Patient #9: a female patient experienced a left femur fracture and was implanted with an angled blade plate and screws on an unknown date. X-rays on (b)(6) 2004 showed an non-union and three (3) screws pulled out. Patient was returned to the operating room on an unknown date and the 3 screws were removed and surgeon used cerclage wire to hold the plate. Eventually the entire construct was removed, unknown date, and the patient was revised to a straight plate. It can not be verified if the product is synthes product. This is 5 of 5 reports for this event.
Patient Sequence No: 1, Text Type: D, B5


[9825168] Without a lot number the device history records review could not be completed. The investigation could not be completed, no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2520274-2012-00974
MDR Report Key2603458
Report Source00,07
Date Received2012-06-04
Date of Report2010-10-01
Date Mfgr Received2010-10-01
Date Added to Maude2012-06-08
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 FDA0
Event Location0
Manufacturer ContactMS SHERRY LAING
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone8006207025
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePINS/WIRES
Product CodeDZK
Date Received2012-06-04
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-06-04

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