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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SYNFLATE BALLOON/LARGE- STERILE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 03.804.702S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Additional product code: hrx. The investigation could not be completed, no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot: part #: 03. 804. 702s. Synthes lot #: h888514. Supplier lot #: h888514. Release to warehouse date: may 18, 2020. Expiration date: feb 01, 2022. Supplier: confluent medical technologies. No ncr's generated during production. 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) 2021, the patient underwent for a surgery. During the surgery, to inject cement into the vertebra, the surgeon tried to inflate a balloon before inserting it into the patient's body and discovered that the balloon was defective and had a significant leak in the area of the connections - a punch or hole in the plastic. It was unknown the surgery completed successfully. There were no patient consequences are reported. This complaint involves one (1) device. This report is for (1) synflate balloon/ large-sterile this report is 1 of 1 for (b)(4).
 
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Brand NameSYNFLATE BALLOON/LARGE- 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 Key12219556
MDR Text Key263498045
Report Number8030965-2021-06056
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K130146
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
Report Date 06/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.804.702S
Device Lot NumberH888514
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 Received06/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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