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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONUS II-5CC ALLOGRAFT BONE

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ZIMMER BIOMET, INC. BONUS II-5CC ALLOGRAFT BONE Back to Search Results
Model Number N/A
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 11/12/2015
Event Type  malfunction  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Review of the dhr found the product was released to distribution with no deviations or anomalies. Review of the complaint history determined that no further action is required as no were trends identified. Current information is insufficient to permit conclusions as to the cause of the events. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. (b)(4).
 
Event Description
It was reported that during a clavicle fracture procedure the bonus demineralized bone matrix (dbm) was combined with bone marrow concentrate (bmc), dbm did not soften. The surgeon crushed the dbm and soaked it with the bmc that was left over. The resulting mixture was put into the fracture to complete the procedure.
 
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Brand NameBONUS II-5CC
Type of DeviceALLOGRAFT BONE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6903605
MDR Text Key88150600
Report Number0001825034-2017-07565
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
PNOT LISTED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2017
Device Model NumberN/A
Device Catalogue Number48-DBM5
Device Lot Number792060
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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