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U.S. Department of Health and Human Services

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

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SYNTHES GMBH SYNFLATE BALLOON/MEDIUM- STERILE CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Catalog Number 03.804.701S
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
Additional procode: hrx. Part:03. 804. 701s. Synthes lot: h892250. Supplier lot: n/a. Release to warehouse date: october 22, 2020. Expiration date: n/a. Supplier: (b)(6). No nonconformance reports (ncrs) were generated during production. Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the received image(s). The image(s) was reviewed, and the complaint condition was confirmed as the image showed the needle sticking out of the balloon indicating it did not inflate correctly. As the instrument(s) was not returned, an as received, dimensional, material or drawing reviews are not applicable. A manufacturing record evaluation was performed, and no issues were noted. There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown. No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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 the (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the blue end on the inflating guide was sticking out of the balloon, meaning that the balloon inflated unevenly. The defect was noticed once the balloon was removed from the patient. The equipment was discarded, and replacements used. Procedure was completed with a ten (10) minute delay. There was no patient consequence. This report is for a synflate balloon/medium- sterile. This is report 1 of 1 for (b)(4).
 
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Brand NameSYNFLATE BALLOON/MEDIUM- 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 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11850081
MDR Text Key252627761
Report Number8030965-2021-04034
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeUK
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 04/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.804.701S
Device Lot NumberH892250
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 Received04/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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