UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[184710841] This report is for an unk - cable/ wire accessories: orthopaedic cable/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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


[184710842] It was reported that on an unknown date, the patient had plate and screws implanted ten years ago that seem to be reacting to. The patient's doctor said it may be a nickel allergy but believed it was titanium. The patient wants to know what the following implants are made up of. Titanium implants ticp do not contain nickel. Stainless steel implants do contain nickel. There was no surgery delay reported and patient outcome unknown. This complaint involves nine (9) devices. This is 8 of 9 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01478
MDR Report Key9868250
Report SourceCONSUMER
Date Received2020-03-23
Date of Report2020-02-24
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-23
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE
Generic NameWIRE, SURGICAL
Product CodeLRN
Date Received2020-03-23
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-23

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