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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT

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OBERDORF : SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 07.702.016S
Device Problems Failure to Cycle (1142); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2017
Event Type  malfunction  
Manufacturer Narrative
Device history records review was completed for part# 07. 702. 016s, lot# 7d53203. Manufacturing location: selzach, supplier: aap biomaterials gmbh. Release to warehouse date: aug 21, 2017, expiry date: apr 01, 2020. No non-conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Product development investigation was completed. Supplied cement kit was analyzed by the supplier. Upon disassembling and inspection of the system, it was noted that the cement powder has not been mixed with the monomer, the piston has been moved to minimize the mixing chamber. This error could have blocked the paddle or caused problems during mixing of cement. As possible preventive action to avoid similar problems in the future, it is recommended to have short training of the user by an expert of synthes. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. H11 corrected data: d1 e1: reporter facility name and address. 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
Additionally, it was reported that there was five minutes of delay in surgery as the new vertecem v+ had to be mixed. Reportedly, there was no harm to the patient.
 
Manufacturer Narrative
Patient information is unknown. Device is not distributed in the united states, but is similar to device marketed in the usa. Device is an instrument and is not implanted/explanted. Complainant part has not been returned for manufacturer review/investigation. 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
It was reported that the vertecem v+ mixer handle allowed the pulling and pushing motion, but didn¿t allow rotation of the handle. Therefore the cement could be mixed, but not transferred to the syringes for application.
 
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Brand NameVERTECEM V+ CEMENT KIT
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
michael cote
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key7209301
MDR Text Key253077993
Report Number8030965-2018-50524
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2020
Device Catalogue Number07.702.016S
Device Lot Number7D53203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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