NEUFLEX MCP IMPLANT SZ 60 123460000

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 2017-10-23 for NEUFLEX MCP IMPLANT SZ 60 123460000 manufactured by Depuy Orthopaedics, Inc. 1818910.

Event Text Entries

[89951942] 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


[89951943] Der stated revision of broken neuflex mcp joints in index and middle finger. Both prosthesis broke at their joint.
Patient Sequence No: 1, Text Type: D, B5


[107888800] No device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. The investigation could not draw any conclusions regarding the reported event. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. 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


MAUDE Entry Details

Report Number1818910-2017-27262
MDR Report Key6968658
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2017-10-23
Date of Report2017-09-25
Date of Event2017-09-25
Date Mfgr Received2017-11-02
Date Added to Maude2017-10-23
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 FDA3
Event Location3
Manufacturer ContactCHAD GIBSON
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46581
Manufacturer CountryUS
Manufacturer Postal46581
Manufacturer Phone5743725905
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal Code46582
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEUFLEX MCP IMPLANT SZ 60
Generic NameFINGER IMPLANT
Product CodeKYJ
Date Received2017-10-23
Catalog Number123460000
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-10-23

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