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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 Activation, Positioning or SeparationProblem (2906)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa. Manufacturing location: supplier - confluent / inspected and released by: (b)(4). Release date: june 26, 2020. Expiration date: may 01, 2023. Part: 09. 804. 502s, vertrebal body stent-large. Lot : h89023 (sterile). Purchased finished goods traveler met all inspection acceptance criteria. Certificate of conformance supplied by confluent was reviewed and determined to be conforming. Inspection sheet, incoming final inspection met all inspection acceptance criteria. Packaging was reviewed per inspection sheet requirements and determined to be conforming. This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition. 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 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 procedure on (b)(6) 2020, the surgeon inserted both stents into the vertebral body and after x-ray control wanted to retract the stent slightly. Unfortunately, the stent remained in place and the surgeon retracted only the balloon. The surgeon then inserted a new stent, which he inflated successfully. Procedure was completed successfully with a delay of ten (10) minutes. There was no patient consequence. This report is for a vertebral body stent-large. This is report 1 of 1 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)
SYNTHES MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11140736
MDR Text Key229600531
Report Number8030965-2021-00172
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
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.502S
Device Lot NumberH890231
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 Received12/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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

Patient Treatment Data
Date Received: 01/08/2021 Patient Sequence Number: 1
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