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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY STENT-LARGE POLYMETHYLMETHACRYLATE BONE CEMENT

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OBERDORF SYNTHES PRODUKTIONS GMBH VERTEBRAL BODY STENT-LARGE POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 09.804.502S
Device Problems Difficult to Open or Close (2921); Device Handling Problem (3265)
Patient Problems No Patient Involvement (2645); No Code Available (3191)
Event Date 09/02/2019
Event Type  malfunction  
Manufacturer Narrative
Device returned. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. 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. G510(k) pending clearance - spine.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that dr. San millan try to implant the vbs system and the stent was unable to open properly, the surgery was delayed 20 minutes due to the reported event and had to change the stent. Procedure was successfully completed and no fragments generated. Patient status/ outcome / consequences is unknown. Medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: this complaint involves one (1) device. This report is 1 of 1 for (b)(4).
 
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Brand NameVERTEBRAL BODY STENT-LARGE
Type of DevicePOLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
SYNTHES SELZACH
bohackerweg 5
selzach 2545
SZ 2545
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6103142063
MDR Report Key9137160
MDR Text Key160665306
Report Number8030965-2019-68867
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 09/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Catalogue Number09.804.502S
Device Lot Number0218016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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