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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VBS W/BALLOON SM CEMENT, BONE, VERTEBROPLASTY

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SYNTHES GMBH VBS W/BALLOON SM CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 09.804.600S
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. 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 (b)(6) 2021, during a percutaneous vertebroplasty (l1) to treat compression fracture, the trial balloon was applied without any issue. Next, the surgeon inserted the stent balloon. While the stent balloon was being inflated, it slid forward. So, he deflated the stent balloon and retried inflation. Right after he confirmed the inflation, the stent balloon burst. Surgeon collected leaked contrast medium and cleansed the lesion with saline. The rest of the procedure was completed with a less than thirty (30) minutes surgical delay. No further information is available. This report is for one (1) vbs w/balloon sm. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameVBS W/BALLOON SM
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
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 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12537612
MDR Text Key273560660
Report Number8030965-2021-08079
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.600S
Device Lot NumberJ002434
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 Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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