MAUDE MDR 9622941

MDR report key: 9622941
Report number: 2939274-2020-00376
Event key: 0
Event type: 3
Date received: 2020-01-23
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: KARA DITTY-BOVARD
Address: 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
Phone: 610-610-6103
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	4.5 VACRVD CONDY PL/18H/370/LT	IMPLANT,FIXATION DEVICE, CONDYLAR PLATE	WRIGHTS LANE SYNTHES USA PRODUCTS LLC	JDP		02.124.419					R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-01-23	0	1. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
07899258636658	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2025-04-25
07899258654560	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2025-04-25
07899258654706	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2025-04-25
07899258607887	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258607894	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258607900	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654850	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654867	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654874	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654881	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654898	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654904	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654911	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654928	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654935	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654942	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654959	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654966	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654973	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654980	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258654997	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258655000	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258655017	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258655024	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258655048	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258655338	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258657714	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258657721	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258657738	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17
07899258657745	Versalock Periprosthetic Femur Plates System-GMReis	GM DOS REIS INDUSTRIA E COMERCIO LTDA	JDP	2024-01-17

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K162124	JDP	Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins	DePuy Synthes	2017-03-29
510(k)	K110354	JDP	4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM	Synthes USA	2011-03-04

MAUDE MDR 9622941

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

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