MAUDE Adverse Event Report: BIOMET MICROFIXATION ALLOGENIX DEMINERALIZED BONE SUBSTITUTE; BONE VOID FILLER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown if other zimmer biomet products were implanted at this time.The product was discarded by the hospital and therefore will not be returned for an evaluation.Because the part and lot numbers are unknown, the device history records could not be pulled and reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

A revision due to infection was reported for a trauma patient.More information was requested but has yet to be received.

• Brand Name: ALLOGENIX DEMINERALIZED BONE SUBSTITUTE
• Type of Device: BONE VOID FILLER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6222132
• MDR Text Key: 63855253
• Report Number: 0001032347-2016-00775
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention