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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11CC; CEMENT, BONE, VERTEBROPLASTY
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MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11CC; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number 283910000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that during the surgery process, when using the confidence cement with the hydraulic pump that allows the cement to escape failed and the water came out of the pump.This should not have been the case, the liquid must push internally until the cement comes out.Another confidence kit was used, which worked very well.There was no patient consequence.This report is for one (1) confidence spinal cement system confidence plus kit spinal cement system 11cc.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: part: 283910000; lot: 273916; the device history record (dhr)was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: march 03, 2020.Visual inspection: confidence spinal cmt sys, 11c was returned and received at us customer quality (cq).The whole kit was not returned at cq.Cement reservoir and mixer were not received at cq.Upon visual inspection, it was observed that the cement was hardened inside the injector body.No components were found to be misassembled.Functional testing: the functional test was failed to perform on the returned device as no liquid was left inside the pump.Dimensional inspection: no dimensional inspection can be performed at cq due to the design of the device.Document/specification review: the following drawings were reviewed.Confidence final package assembly; confidence pump kit packaging; confidence pump assembly.No design issues or discrepancies were noticed.Investigation conclusion: the complaint condition was not confirmed for the confidence spinal cmt sys, 11c as no components were found to be misassembled.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: the complaint product is not available to return.The customer is retaining the product.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.
 
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Brand Name
CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11CC
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10691915
MDR Text Key211761565
Report Number1526439-2020-01982
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public10705034209623
Combination Product (y/n)N
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2022
Device Model Number283910000
Device Catalogue Number283910000
Device Lot Number273916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2020
Date Manufacturer Received12/08/2020
Patient Sequence Number1
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