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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW BONE SCREW

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BIOMET MICROFIXATION "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW BONE SCREW Back to Search Results
Model Number N/A
Device Problem Retraction Problem
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical product: biomet microfixation tmj system right narrow mandibular component catalog #: 01-6545 lot #: 584440d, biomet microfixation tmj system left narrow mandibular component catalog #: 01-6546 lot #: 550140d, biomet microfixation tmj system right fossa component, small catalog #: 24-6562 lot #: 651420a, biomet microfixation tmj system left fossa component, small catalog #: 24-6563 lot #: 682520b, biomet microfixation "2. 4mm" system ht cross-drive screw catalog #: 91-2708 lot #: ni, biomet microfixation tmj system cross drive fossa screw catalog #: 99-6577 lot #: ni, biomet microfixation "2. 7mm" system emergency cross drive screw catalog #: 99-9950 lot #: ni. Customer has indicated that the product will not be returned to zimmer biomet for investigation, the devices remain implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00239 through 0001032347-2018-00246.

 
Event Description

It was reported by the patient's father "issues have risen" and a replacement is being considered. Upon follow up it was reported her "surgeons are evaluating replacing her current jaw joints with two custom designed joints because she has had some retraction in the forward jaw movement. The angle of her mandible is still quite steep and her biting and chewing surfaces don¿t line up properly. The patient has said that occasionally she experiences some discomfort on the left side after chewing for more than a few minutes. " no additional patient consequences were reported.

 
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Brand Name"2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW
Type of DeviceBONE 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 Key7488405
Report Number0001032347-2018-00244
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 10/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number91-2710
Device LOT NumberUNKNOWN
OTHER Device ID Number(01)00841036053642
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
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 Initial

Patient TREATMENT DATA
Date Received: 05/04/2018 Patient Sequence Number: 1
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