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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELMIRA UNK - PLATES: MATRIXNEURO PLATE, FIXATION ,BONE   

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ELMIRA UNK - PLATES: MATRIXNEURO PLATE, FIXATION ,BONE    Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown matrixneuro plate/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on (b)(6) 2021 the patient underwent an orbital zygomatic medial sphenoid wing craniotomy for meningioma. The procedure was successfully completed. Three (3) to four (4) moths post-op the patient had a reaction to the synthecel that had been implanted. A revision operation was performed to remove the synthecel. Results from the specimen that had been sent to pathology were as follows: no infection, fibrosis of foreign body type tissue reaction, histiocytes. Surgicel, surgicel nu-knit, flowseal, irrisept, neurolon for suture, vicryl suture, cranios, matrixneuro plating system were also used during the case. This report is for one (1) unknown matrixneuro plate. This is report 3 of 3 for (b)(4).
 
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Brand NameUNK - PLATES: MATRIXNEURO
Type of DevicePLATE, FIXATION ,BONE   
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12746040
MDR Text Key279888059
Report Number8030965-2021-09254
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
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?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/03/2021 Patient Sequence Number: 1
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