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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT

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MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 283910000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.
 
Event Description
Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 a revision surgery of a posterior decompression and fusion (l4/5) with verse was performed.While cementing the l4 screw there was an anterolateral leak from the vertebral body.The surgeon stopped the cement delivery for this particular screw and suggested that there had not been a lateral or anterior breach when placing the screw, that it was likely that the bone around the screw was sclerotic leading to the cement leakage rather than flowing from the fenestrations.Concomitant device reported: unknown screw (part#: unknown, lot#: unknown, quantity: 1).This report is for one confidence plus kit spinal cement system 11 cc.This is report 1 of 1 for (b)(4).
 
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Brand Name
CONFIDENCE SPINAL CMT SYS, 11C
Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9496288
MDR Text Key177175798
Report Number1526439-2019-52733
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public10705034209623
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number283910000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/27/2019
Initial Date FDA Received12/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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