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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SYNFLATE BALLOON/LARGE- STERILE CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 03.804.702S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date during a kyphoplasty procedure, two needles were inserted into the patient's vertebrae (bi-lateral approach). After inserting the needles, the surgeon decided to switch the needles to the ones in the synflate kit in order to use a balloon. The needles got stuck in the patient's vertebrae and a lot of force was used to try to get them out. One (1) needle came out and the other one (1) detached from the handle because of the force that was used. While pulling the needle out it broke and an open procedure needed to be performed. After preforming a small incision, the surgeon reached the base of the vertebrae and pulled whatever he could from the needle. A part of the needle remained in the vertebrae. In addition, after inserting the synflate's balloon and inflating it, the balloon ripped and failed under the pressure (although the bar didn't reach the maximum level permitted). There was a surgical delay of one (1) hour. Concomitant medical products: access kit 10 g diam tip side-open doubl (part# 03. 804. 514s, lot# unknown, quantity 1) inflation system ( part# 03. 804. 413s, lot# unknown, quantity 1). This report is for one (1)synflate balloon/large- sterile. This is report 1 of 1 for (b)(4). This report is related to (b)(4).
 
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. 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.
 
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Brand NameSYNFLATE BALLOON/LARGE- STERILE
Type of DeviceCEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11783460
MDR Text Key280508331
Report Number8030965-2021-03607
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K130146
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
Report Date 04/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.804.702S
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 Received04/09/2021
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

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