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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/SMALL- STERILE POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH SYNFLATE BALLOON/SMALL- STERILE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 03.804.700S
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Event occurred on an unknown date in 2021. Additional procode: hrx. 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021, the synflate balloon connection was defective and unable to connect the syringe to the side luer. There was no surgical delay. The procedure was successfully completed using a new device. There was no patient consequence. This report is for one (1) synflate balloon/small- sterile. This is report 1 of 1 for (b)(4).
 
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Brand NameSYNFLATE BALLOON/SMALL- STERILE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12211118
MDR Text Key262981504
Report Number8030965-2021-05987
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K130146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.804.700S
Device Lot NumberJ002431
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 Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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