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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW, 1/PKG SCREW, FIXATION, BONE

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BIOMET MICROFIXATION "2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW, 1/PKG SCREW, FIXATION, BONE Back to Search Results
Model Number N/A
Device Problem Noise, Audible
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: biomet microfixation tmj system right narrow titanium mandibular component, 45 mm, catalog #: 01-6545ti, lot #: 817540a; biomet microfixation tmj system left standard titanium mandibular component, 45 mm, catalog #: 24-6546ti, lot #: 721710; biomet microfixation tmj system right fossa component, small, catalog #: 24-6562, lot #: 797600; biomet microfixation tmj system left fossa component, small, catalog #: 24-6563, lot #: 795320; biomet microfixation 2. 4 mm system high torque (ht) cross-drive screw, catalog #: 91-2708, lot #: ni; biomet microfixation ttmj system cross drive fossa screw, catalog #: 99-6577, lot #: ni; biomet microfixation tmj system cross drive emergency fossa screw, catalog #: 99-6587, lot #: ni; biomet microfixation 2. 7 mm system emergency cross drive screw, 1 pkg, catalog #: 99-9948, lot #: ni. Therapy date: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains 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: 0001032347-2019-00078 through 0001032347-2019-00085.

 
Event Description

It was reported by the patient that the patient is experiencing nerve damage on the right side that her surgeon said would go away but it hasn't. She is also experiencing misalignment of her teeth which makes it difficult for her to chew food like steak, numbness from the middle of the bottom lip to her right ear, and squeaking. Her surgeon informed her that her issues are likely due to her small anatomy. The patient did not receive any intervention for her symptoms. No additional patient consequences were reported.

 
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Brand Name"2.7MM" SYSTEM EMERGENCY CROSS DRIVE SCREW, 1/PKG
Type of DeviceSCREW, FIXATION, BONE
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 Key8312513
Report Number0001032347-2019-00086
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number99-9950
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2019
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
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 02/06/2019 Patient Sequence Number: 1
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