• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES SELZACH SYNFLATE BALLOON/MEDIUM-STERILE POLYMETHYLMETHACRYLATE BONE CEMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SYNTHES SELZACH SYNFLATE BALLOON/MEDIUM-STERILE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 03.804.701S
Device Problem Difficult to Open or Close (2921)
Patient Problem No Code Available (3191)
Event Date 01/13/2016
Event Type  Injury  
Manufacturer Narrative
Additional narrative: patient id/initials, age/date of birth, and weight are unknown. Additional product code: hrx. (b)(6). Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). Capture extra intra-operative x-rays. The investigation could not be completed; no conclusion could be drawn, as no product was received. Manufacturing site: (b)(4). Supplier: (b)(4). Manufacturing date: february 11, 2015. Expiry date: december 01, 2016. No non-conformance reports were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 in (b)(6) as follows: it was reported that during t6/t7 kyphoplasty surgery after balloon inflation, the balloons did not deflate correctly in order to be removed from the working sleeve. The surgery was therefore prolonged about ten (10) minutes. There was no patient harm. The problem was solved by removing both the working sleeve and balloon together instead of the balloon being removed through the working sleeve. This meant that the working sleeve had to be reintroduced for cement introduction. This added time and extra x-ray exposure for the patient. Once this extra step was completed, the operation continued as normal to a satisfactory outcome. This is report 3 of 3 for (b)(4).
 
Manufacturer Narrative
Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. 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.
 
Manufacturer Narrative
A manufacturing evaluation was completed: the balloons were deflated and powdery contrast medium residue was observed in all three balloons. It was reported that three synflate m instruments did not deflate properly and could not be removed through the working sleeve. The review of the manufacturing history of the three production lots did not reveal any nonconformity. The complaint instruments were manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection. During the technical investigation all three instruments could be inflated and deflated without problems. The instruments could hold vacuum and reached a fully deflated state. It seems likely that the root cause for the complaint event is related to external factors during the procedure (e. G. Saline/contrast medium mixture too viscous, not holding vacuum during withdrawal). Complaint is unconfirmed as it was not possible to reproduce the complained malfunction. No manufacturing related issue was identified. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNFLATE BALLOON/MEDIUM-STERILE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer (Section G)
SYNTHES SELZACH
bohnackerweg 5
selzach CH254 5
SZ CH2545
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key5403708
MDR Text Key37302797
Report Number3000270450-2016-10026
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK130146
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2016
Device Catalogue Number03.804.701S
Device Lot Number1114040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/02/2016 Patient Sequence Number: 1
-
-