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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK MESH, SURGICAL

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SYNTHES GMBH SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK MESH, SURGICAL Back to Search Results
Catalog Number 08.510.120S
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 09/24/2020
Event Type  Injury  
Manufacturer Narrative
Additional procodes: ftl, gwo. 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. (b)(4). 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 (b)(6) reports an event as follows: it was reported that during a blowout fracture repair on (b)(6) 2020, the synpor sheet was damaged during the cutting process. The sheet cracked easily. The surgeon used a non-synthes product instead. The procedure was completed with no delay. Patient status was normal. This report is for a synpor square sheet. This is report 1 of 1 for (b)(4).
 
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Brand NameSYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES BME : SAN ANTONIO
14785 omicron drive
#205
san antonio TX
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key10704026
MDR Text Key212317734
Report Number8030965-2020-08056
Device Sequence Number1
Product Code FTM
UDI-Device Identifier07611819315853
UDI-Public(01)07611819315853
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K051879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number08.510.120S
Device Lot NumberDS7000796
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 Received11/06/2020
Was Device Evaluated by Manufacturer? Yes
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: 10/20/2020 Patient Sequence Number: 1
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