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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE MESH,SURGICAL

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE MESH,SURGICAL Back to Search Results
Model Number 08.510.640S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional procode: gwo, ftl. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 during an unknown procedure on an unknown date, the film from polyethylene implant that was supposed to be on top of the synpor smooth orbital floor plate was delaminated and peeling off. The procedure was successfully completed with the use of another implant. There was no surgical delay, and no patient consequence reported. This report is for one (1) synpor smooth orbital floor plate 24mm/0. 8mm thk-sterile. This is report 1 of 1 for (b)(4).
 
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Brand NameSYNPOR SMOOTH ORBITAL FLOOR PLATE 24MM/0.8MM THK-STERILE
Type of DeviceMESH,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES BME : SAN ANTONIO
14785 omicron drive
#205
san antonio TX 78245
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10645362
MDR Text Key210406399
Report Number2939274-2020-04569
Device Sequence Number1
Product Code FTM
UDI-Device Identifier10887587026244
UDI-Public(01)10887587026244
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2022
Device Model Number08.510.640S
Device Catalogue Number08.510.640S
Device Lot NumberDSE5437
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 Received10/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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