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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, 2.7 X 10MM BONE SCREW

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BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10MM BONE SCREW Back to Search Results
Model Number N/A
Device Problems Insufficient Information; Noise, Audible
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical product: biomet microfixation tmj system right fossa component, small catalog #: 24-6562, lot #: 377870c; biomet microfixation tmj system right titanium mandibular component, catalog #: 01-6545, lot #: 372370a; biomet microfixation "2. 4mm" system ht cross-drive screw, 2. 7x10mm, catalog #: 91-2710, lot #: ni; and biomet microfixation tmj system cross drive fossa screw, 2. 0x7mm catalog #: 99-6577, lot #: ni; therapy date: unknown. (b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted. 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: 0001032347-2019-00011, 0001032347-2019-00012, 0001032347-2019-00013, and 0001032347-2019-00015.

 
Event Description

It was reported by the patient that she did not have insurance that would cover the type of intervention needed. She¿s had more problems since being implanted than prior to implants; two years after implantation, she¿s experienced multiple episodes of blood coming from her ears and nose, coughing up blood, consistent swelling in her mouth, and constantly hearing squeaky noises throughout the day coming from the implant. She also stated her surgeon relocated to florida. No additional patient consequences were reported.

 
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Brand Name2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 2.7 X 10MM
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 Key8219865
Report Number0001032347-2019-00014
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number91-2712
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 Received01/04/2019
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

Patient TREATMENT DATA
Date Received: 01/04/2019 Patient Sequence Number: 1
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