UNK - SCREWS: TRAUMA

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 2020-03-31 for UNK - SCREWS: TRAUMA manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185919435] This report is for an unknown screw/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is patient. No details available. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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


[185919436] It was reported that a patient had an allergic reaction to the metal of the implant and that caused issues with her immune system. The product that was implanted was for ankle surgery, a synthes 1/3 tubular plate and a small fragment system with 8 screws. This is report 7 of 9 for (b)(4). This report is for an unknown screw.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01641
MDR Report Key9907690
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 - SCREWS: TRAUMA
Generic NameSCREW, FIXATION, BONE
Product CodeHWC
Date Received2020-03-31
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 2020-03-31

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