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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE MESH,SURGICAL

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OBERDORF SYNTHES PRODUKTIONS GMBH SYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE MESH,SURGICAL Back to Search Results
Catalog Number 08.510.541S
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/12/2019
Event Type  malfunction  
Manufacturer Narrative
Additional device product codes: gwo, ftl. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is synthes sales consultant. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an orbital repair to the eyelid, a synpor orbital floor plate was disintegrated upon insertion. Thus, the surgeon replaced the plate with a new one. There was a surgical delay of 5-10 minutes. The procedure was successfully completed with no adverse consequence to the patient. This report is for one (1) synpor orbital floor plate 30 mm/0. 8 mm thick-sterile this is report 1 of 1 for complaint (b)(4).
 
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Brand NameSYNPOR ORBITAL FLOOR PLATE 30MM/0.8MM THICK-STERILE
Type of DeviceMESH,SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8777006
MDR Text Key150674583
Report Number8030965-2019-66128
Device Sequence Number1
Product Code FTM
UDI-Device Identifier07611819315914
UDI-Public(01)07611819315914
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K051879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number08.510.541S
Device Lot NumberDS7001864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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