UNKNOWN BIOMATERIAL - CEMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-04 for UNKNOWN BIOMATERIAL - CEMENT manufactured by Depuy Spine Inc.

Event Text Entries

[178226831] If the information is unknown, not available or does not apply, the section/field of the form is left blank. 510k: this report is for an unknown biomaterial - cement/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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


[178226832] Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the confidence 7. Cement was mixed and refueled in hydraulic syringe. After the handle of hydraulic pump was rotated by surgeon, liquid permeated in the cement. This report is for one unknown biomaterial - cement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1526439-2020-00494
MDR Report Key9668110
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-04
Date of Report2020-01-13
Date Mfgr Received2020-03-05
Date Added to Maude2020-02-04
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 Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN BIOMATERIAL - CEMENT
Generic NamePOLYMETHYLMETHACRYLATE BONE CEMENT
Product CodeNDN
Date Received2020-02-04
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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