MAUDE Adverse Event Report: BIOMET MICROFIXATION LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING; 2.7X8MM HT X-DRIVE SCREW

Model Number N/A

Device Problem Biological Environmental Factor (2887)

Patient Problems Fistula (1862); Headache (1880); Hearing Loss (1882); Nausea (1970); Pain (1994); No Code Available (3191)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown; therefore the device history records are unable to be reviewed.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.Report five of eight for the same event, reference 1032347-2016-00472 through 1032347-2016-00479.

Event Description

The patient reported experiencing headaches, hearing loss, and additional surgeries.The surgeon's office was contacted and it was reported the patient underwent a bi-lateral revision of christiansen implants in (b)(6) 2015 which were replaced with biomet implants.On (b)(6) 2015 the patient returned complaining of severe nausea and was diagnosed with a fistula of the left auditory canal.It was determined the patients bite was not aligned and the left side was re-aligned at that time.On (b)(6) 2016 the patient returned stating the implant was still causing pain.Biological failure of the implant was identified and a complete revision was necessary.The biomet implants were explanted (b)(6) 2016.On (b)(6) 2016 patient followed up and was documented as healing well and in good condition.

• Brand Name: LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING
• Type of Device: 2.7X8MM HT X-DRIVE SCREW
• 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: 5934218
• MDR Text Key: 54116966
• Report Number: 0001032347-2016-00476
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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: 91-2708
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention