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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 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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 percutaneous vertebroplasty treating l1 compression fracture surgery. The trial balloons broke. The procedure was completed less than 30-minute surgical delay. There was no adverse patient effect. No further information is available. This complaint involves (2) devices. This report is for (1) vbs w/balloon sm. This report is 1 of 2 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 Key12336250
MDR Text Key267058923
Report Number8030965-2021-06769
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
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 Received09/17/2021
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: 08/18/2021 Patient Sequence Number: 1
Treatment
VBS W/BALLOON SM
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