MAUDE Adverse Event Report: BIOMET MICROFIXATION CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER; METHYL METHACRYLATE FOR CRANIOPLASTY; 25G MIMIX

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.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

It was reported the mimix did not perform as intended during a cranioplasty.The surgery was completed using another bone cement not manufactured by zimmer biomet.A thirty minute surgical delay was reported; no injury to the patient was reported.

• Brand Name: CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
• Type of Device: METHYL METHACRYLATE FOR CRANIOPLASTY; 25G MIMIX
• 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: 6314079
• MDR Text Key: 67159427
• Report Number: 0001032347-2017-00094
• Device Sequence Number: 1
• Product Code: GXP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PK990290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 02-2025
• Device Lot Number: 858600
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1