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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VBS SMALL CEMENT, BONE, VERTEBROPLASTY

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SYNTHES GMBH VBS SMALL CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 09.804.500S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
Additional product code: hrx. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. Reporter is a j&j sales representative. 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 surgery he did not inflate the vbs balloon. Procedure was successfully completed with five(5) minutes delay. Fragments were generated but was not removed and no patient consequences. This report is for one (1) vertebral body balloon/small- sterile. This is report 1 of 2 for complaint (b)(4).
 
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Brand NameVBS SMALL
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK BIO OBERDORF (CH)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12076560
MDR Text Key258741392
Report Number8030965-2021-05366
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodePE
PMA/PMN Number
K110604
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 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number09.804.500S
Device Lot Number002420
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 Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2020
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: 06/28/2021 Patient Sequence Number: 1
Treatment
INFLATION SYSTEM; INFLATION SYSTEM; VBS SMALL
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