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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE ELSHEBANI LEFT PM-TMJ & MODEL; CUSTOM MADE TMJ

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BIOMET MICROFIXATION CUSTOM MADE DEVICE ELSHEBANI LEFT PM-TMJ & MODEL; CUSTOM MADE TMJ Back to Search Results
Model Number N/A
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Additional concomitant medical products: biomet microfixation screws catalog #: ni, lot #: ni.Therapy date: (b)(6) 2019.(b)(6).Pma/510(k) number: this product is not cleared or distributed in the u.S.However, this report is being submitted as biomet microfixation manufactures a similar device that is cleared or distributed in the united states under pma number (b)(4) customer has indicated that the product will not be returned to zimmer biomet for investigation it was 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 in (b)(6): during surgery: in the first phase it has been implanted as intended, but the occlusion did not fit.For that reason the surgeon decided intraoperatively to solve the three fixed screws and to move the both mandibular.Patient matched implant.Approximately 2 mm to the procedure.Condylaris (cranial) above.Theory: the opened, denture of the front teeth has been closed, as the mandible rotate against the clockwise direction.It hasn´t taken into account, that the mandible above the maxilla-molars move and for that reason the ramus extended vertical, and for that reason the new jaw angle is low as at the starting point.During the development is visible that the jaw angle is at the same.Height as previously, which is not possible, due to as result the ramus contracted.The mandibular component has been removed approx.2mm to the fossa direction.The ct scan will be made postoperative.The ct has been done.Postoperative - please compare the pre surgery data with the planning, if this theory is correct.The patient is fine and the occlusion is functioning.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
 
Event Description
It was determined that the part information initially provided was incorrect.The investigation that has been completed thus far is invalid as it has been for the wrong part number and patient.For the initial part number provided tmjpm-2329, the sales associated reported that there was no complaint.The correct part number is tmjpm-2347.
 
Manufacturer Narrative
It was determined that the part information initially provided was incorrect.The investigation that has been completed thus far is invalid as it has been for the wrong part number and patient.For the initial part number provided tmjpm-2329, the sales associate reported that there was no complaint.The correct part number is tmjpm-2347.A new complaint has been created to investigate the correct part number which is captured in cmp-0506055 and mfr# 0001032347-2019-00297.
 
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Brand Name
CUSTOM MADE DEVICE ELSHEBANI LEFT PM-TMJ & MODEL
Type of Device
CUSTOM MADE TMJ
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key8322055
MDR Text Key135683182
Report Number0001032347-2019-00095
Device Sequence Number1
Product Code LZD
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/17/2023
Device Model NumberN/A
Device Catalogue NumberTMJPM-2329
Device Lot Number874730A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/09/2019
Initial Date FDA Received02/08/2019
Supplement Dates Manufacturer Received05/22/2019
Supplement Dates FDA Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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