SLF TAPPING ROOF PILE SCRW25MM 101140025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-12-01 for SLF TAPPING ROOF PILE SCRW25MM 101140025 manufactured by Depuy Orthopaedics, Inc. 1818910?.

Event Text Entries

[129016290] (b)(4). 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


[129016291] Ppf and sticker sheets received. Ppf alleges pulmonary embolism.
Patient Sequence No: 1, Text Type: D, B5


[130545193] (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should 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, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1818910-2018-76845
MDR Report Key8121999
Report SourceCONSUMER,OTHER
Date Received2018-12-01
Date of Report2018-11-06
Date Mfgr Received2018-12-03
Device Manufacturer Date2009-11-02
Date Added to Maude2018-12-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSLF TAPPING ROOF PILE SCRW25MM
Generic NameBONE SCREWS AND PINS : SCREWS
Product CodeJDJ
Date Received2018-12-01
Catalog Number101140025
Lot NumberD5LDL1000
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 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-12-01

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