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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION CUSTOM MADE DEVICE 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  malfunction  
Manufacturer Narrative
(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.Concomitant medical product: biomet microfixation screws catalog #: ni lot #: ni.Report source - foreign country: (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 p020016.
 
Event Description
It was reported that the prostheses did not fit as expected.During the implant surgery, the product was implanted as intended, but the occlusion did not fit.The surgeon removed three screws and repositioned the mandibular components.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint cannot be verified, as the product remains implanted and the customer did not provide post-operative ct data.Upon review of the digital design files, the vendor concluded the final splint, mandibular and fossa component samples, and guides were designed according to all applicable procedures per wi 470-500 tmj component design.All of the components of tmjpm-2347 (b)(4)) were inspected for shape and fit as per li0859 & li0860 by trained zb engineering personnel prior to distribution.The dhrs of the components for tmjpm-2347 (b)(4)) were reviewed and there were no anomalies found.The most likely underlying cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
This follow-up report is being submitted to relay additional information.
 
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Brand Name
CUSTOM MADE DEVICE PM-TMJ & MODEL
Type of Device
CUSTOM MADE TMJ
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key8638222
MDR Text Key146041662
Report Number0001032347-2019-00297
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 09/10/2019
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 Date11/30/2023
Device Model NumberN/A
Device Catalogue NumberTMJPM-2347
Device Lot Number875210A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/22/2019
Initial Date FDA Received05/23/2019
Supplement Dates Manufacturer Received09/09/2019
Supplement Dates FDA Received09/10/2019
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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