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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE BERG CUSTOM MANDIBLE ONLAYS CUSTOM MADE MANDIBLE

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BIOMET MICROFIXATION CUSTOM MADE DEVICE BERG CUSTOM MANDIBLE ONLAYS CUSTOM MADE MANDIBLE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Deformity/ Disfigurement (2360)
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). (b)(4). Implant date: (b)(6) 2017. Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient stated she is dissatisfied with the implant and a revision is planned. The patient stated that she believes that the implant was not bent properly and as a result, the left side of her chin is bigger and "it looks like a ball coming out of my face. " she stated that she is scheduling a revision for (b)(6). She stated the original procedure occurred in (b)(6) 2017. The sales representative stated the surgeon is not dissatisfied with the design or fit of the implant. However, due to the patient's concerns, a new implant was requested. The revision has not yet been scheduled. No additional patient consequences were reported.
 
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Brand NameCUSTOM MADE DEVICE BERG CUSTOM MANDIBLE ONLAYS
Type of DeviceCUSTOM MADE MANDIBLE
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 Key7856821
MDR Text Key119640274
Report Number0001032347-2018-00604
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation Dentist
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberCP-3018
Device Lot Number786780
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2017
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: 09/07/2018 Patient Sequence Number: 1
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