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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY STENT-LARGE POLYMETHYLMETHACRYLATE BONE CEMENT

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SYNTHES GMBH VERTEBRAL BODY STENT-LARGE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 09.804.502S
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 during an intervention with our vertebral body stent (vbs) it was difficult to open the stent and the stent detached from the balloon. A new vbs needed to be used to finish the intervention. Two (2) vbs stents were inserted into the vertebral body, but neither were able to be inflated. The stents were attempted to be removed, but only the balloons were removed and the unopened stents remained in place. Another balloon was inserted successfully to inflate both stents. After inspection of the first balloons, it was discovered that the balloons were punctured. There was a surgical delay. This report is for one (1) vertebral body stent-large. This is report 2 of 2 for (b)(4).
 
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Brand NameVERTEBRAL BODY STENT-LARGE
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 Key11108839
MDR Text Key224812446
Report Number8030965-2021-00008
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.502S
Device Lot NumberH890231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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