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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TITANIUM MESH IMPLANT MESH, SURGICAL, POLYMERIC

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SYNTHES GMBH UNK - PLATES: TITANIUM MESH IMPLANT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Visual Disturbances (2140)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown preformed titanium mesh implants/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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
This report is being filed after the review of the following journal article: oztel m. , et al (2021) approach: a long-term follow-up of esthetic outcomes and complications, j oral maxillofac surg volume 79, pages 1326-1327 (australia). Https://doi. Org/10. 1016/j. Joms. 2021. 02. 004. This study aims to assess the long-term differences in scarring, cosmesis, and complications between the subtarsal and transconjunctival techniques. From june 2015 to june 2019, 243 patients underwent orbital floor reconstruction with an subtarsal approach (sta) or transconjunctival approach (tca) for a unilateral orbital floor or medial wall fracture at the royal brisbane and women¿s hospital (rbwh), queensland australia. A total of 67 participants were involved in this study. The median age of participants was 36 (interquartile range
=
24). 44 patients (30 males, 14 females) underwent the subtarsal and 22 synthes preformed titanium mesh were used while 23 patients (15 males, 8 females) underwent the transconjunctival approach where 15 synthes preformed titanium mesh were used. Patients were assessed on average 39 months postoperatively (range: 12-72 months). The following complications were reported as follows: subtarsal group: 6 v2 paraesthesia. 3 reoperation, often due to persistent diplopia or plate malposition. 2 enophthalmos. 3 epiphora. 6 diplopia. Transconjunctival group: 6 v2 paraesthesia. 4 reoperation, often due to persistent diplopia or plate malposition. 2 enophthalmos. 2 epiphora. 6 diplopia. This report is for an unknown synthes preformed titanium mesh implants. This is report 1 of 3 for (b)(4).
 
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Brand NameUNK - PLATES: TITANIUM MESH IMPLANT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12349858
MDR Text Key267626370
Report Number8030965-2021-06991
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2021
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: 08/20/2021 Patient Sequence Number: 1
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