DBX 227005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for DBX 227005 manufactured by Musculoskeletal Transplant Foundation, Inc..

Event Text Entries

[177634530] Total hip arthroplasty: surgeon requested 4 of mft biologics aft straight tube (ref: (b)(4)) be opened to the field. With two of them, the surgeon could not get the product out of the tube. He asked for more and we had no more of the straight tubes and had to open a diverted tube (ref: (b)(4)). The diverted one did not work either. I took the diverted tube and two straight tubes off the field and made sure they were wasted in the patient chart. I put the diverted tube back in its package but was not able to know what packages correlated with the two faulty straight tubes. This report includes 1 aft diverted tube (3/4 filled) and its details and 2 aft straight tube (1/2 filled) with only limited details on 2nd package (tube was saved but box not saved).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9665340
MDR Report Key9665340
Date Received2020-02-04
Date of Report2019-12-02
Date of Event2019-11-25
Report Date2019-12-03
Date Reported to FDA2019-12-03
Date Reported to Mfgr2020-02-04
Date Added to Maude2020-02-04
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDBX
Generic NameFILLER, BONE VOID, CALCIUM COMPOUND
Product CodeMQV
Date Received2020-02-04
Catalog Number227005
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMUSCULOSKELETAL TRANSPLANT FOUNDATION, INC.
Manufacturer Address125 MAY STREET EDISON NJ 08837 US 08837


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-04

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