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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH SYNFLATE BALLOON/SMALL- STERILE CEMENT, BONE, VERTEBROPLASTY

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SYNTHES GMBH SYNFLATE BALLOON/SMALL- STERILE CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 03.804.700S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional device product code: hrx. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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)(4) as follows: it was reported that before the intervention the balloon was tested and it was not possible to fill it. The liquid ran out instantly without ever reaching the balloon. There was a twenty (20) minutes surgical delay due to the reported event. Action taken when event occurred was kyphoplastie bwk 6. The procedure was successfully completed. There was no patient consequence. This report is for one (1) synflate balloon/small- sterile. This is report 1 of 1 for complaint (b)(4).
 
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Brand NameSYNFLATE BALLOON/SMALL- STERILE
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 Key12548850
MDR Text Key278148846
Report Number8030965-2021-08136
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K130146
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 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.804.700S
Device Lot NumberH884711
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
Date Device Manufactured01/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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