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U.S. Department of Health and Human Services

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

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BIOMET MICROFIXATION CUSTOM MADE DEVICE JENSEN RIGHT PM-TMJ & MODEL; PATIENT MATCHED 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 Type  malfunction  
Manufacturer Narrative
(b)(4).Report source - foreign country: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the surgeon had difficulties getting the implant to fit.The surgeon had concern about the horizontal cut instead of a custom fitted implant.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint could not be verified.No x-rays, scans, photographs, or physician reports were provided.The product was not returned and no functional tests or inspections could be performed.The design vendor reviewed the digital design of the right fossa and mandible implants and marking guides and determined that they fit correctly to the patient's anatomy, the screw hole locations were correct, and the products were therefore conforming to design specifications (470-500).The dhrs for the components for tmjpm-2366 (cp755274 & cp755275) were reviewed and no anomalies were found.The most likely underlying cause of the complaint could not be determined based on information and materials provided.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 JENSEN RIGHT PM-TMJ & MODEL
Type of Device
PATIENT MATCHED TMJ
Manufacturer (Section D)
BIOMET MICROFIXATION
1520 tradeport drive
jacksonville FL 32218
MDR Report Key8437990
MDR Text Key139539496
Report Number0001032347-2019-00185
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 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/02/2024
Device Model NumberN/A
Device Catalogue NumberTMJPM-2366
Device Lot Number881460A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/22/2019
Initial Date FDA Received03/20/2019
Supplement Dates Manufacturer Received08/30/2019
Supplement Dates FDA Received08/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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