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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 Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Device is not distributed in the united states, but is similar to device marketed in the usa. Without a lot number the device history records review could not be completed. Product was not returned. 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 (b)(4) reports an event as follows: it was reported that on (b)(6) 2021 a percutaneous vertebroplasty (th11) treating centrum fracture was performed. When the stent balloon was inflated, it fell into the cleft in the centrum. The surgeon was not able to fill the balloon with the cement. The procedure was delayed for less than (30) minutes. It was later confirmed by ct on (b)(6) 2021 that the balloon had been extruded a little from the anterior centrum section. No further adverse effect has been reported. This report is for a balloon. This is report 1 of 1 for (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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12525787
MDR Text Key273107888
Report Number8030965-2021-07983
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 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.600S
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 Received08/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/24/2021 Patient Sequence Number: 1
Treatment
UNK - BIOMATERIAL - CEMENT: VERTECEM
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