4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT 02.124.412

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-19 for 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT 02.124.412 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[139213470] Date of event: event occurred on an unknown date in 2019. Additional product codes: hrs, hwc. (b)(4). Device evaluated by mfr, manufacture date, event problem and evaluation codes: device history lot: part: 02. 124. 412, lot: l824012, manufacturing site: (b)(4), release to warehouse date: 20. Mar. 2018. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. The raw material certificate (b)(4) was reviewed and the used material was according to specification for implants for surgery. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[139213471] It was reported that the patient underwent removal of plate and screws on (b)(6) 2019, due to broken variable angle (va) locking compression plate (lcp) curved condylar right side at the 6th and 7th hole of the shaft of the plate. The patient has an original implant of nine (9) unknown locking screws and two (2) unknown cortex screws on (b)(6) 2019. The patient had been walking on it against the surgeons direction, and a partial weight bearing plate broke. All the implants were removed successfully and the patient was repaired with intramedullary retrograde antegrade femoral nail successfully. There was no surgical delay. Procedure was successfully completed. Patient outcome is unknown. Concomitant devices reported: unk - screws: locking (part# unknown; lot# unknown; quantity 9). Unk - screws: cortex (part# unknown; lot# unknown; quantity 2). This report is for one (1) 4. 5mm va-lcp curved condylar plate/12 hole/266mm/right. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2019-57022
MDR Report Key8432897
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-19
Date of Report2019-02-25
Date of Event2019-01-01
Date Mfgr Received2019-04-26
Device Manufacturer Date2018-03-20
Date Added to Maude2019-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK MEZZOVICO (CH)
Manufacturer StreetVIA CAVAZZ 5
Manufacturer CityMEZZOVICO 6805
Manufacturer CountrySZ
Manufacturer Postal Code6805
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
Generic NameIMPLANT,FIXATION DEVICE, CONDYLAR PLATE
Product CodeJDP
Date Received2019-03-19
Model Number02.124.412
Catalog Number02.124.412
Lot NumberL824012
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-19

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