Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number 283910000
Device Problem Chemical Problem (2893)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2020
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed.No conclusion could be drawn, as no product was received.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 that during a procedure on (b)(6) 2020, the confidence cement set during mixing, before it could be packaged to be applied to the patient.The procedure was successfully completed with no delay.There was no patient consequence.This report is for a confidence spinal cement system.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.H10 additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, h6: the dhr of product code: 283910000, lot : 272685 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 13.02.2020 with qty: 47.Visual inspection: the confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 272685) was returned and received at us customer quality (cq).Upon visual inspection, only confidence pump assembly (p/n: 887014225), mixer kit and the cement reservoir were returned from the kit.The cement was hardened inside the cement reservoir and there was hardening liquid inside the pump.No other issues were identified with the returned device that could impact the device functionality.Functional test: the functional test was failed to perform on the returned device as the cement was solidified.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: a dimensional inspection was not performed as the internal components of the pump and the connector were inaccessible without destruction of the device and the cement was solidified.Document/specification review: following drawings were reviewed, confidence, final packaging assembly, confidence cement reservoir and mixer kit, confidence pump assembly, confidence pump body assembly, confidence sub-assembly pump body, confidence elbow connector v3 body & ifu-0902-90-123.Complaint confirmed? yes.Investigation conclusion: the complaint condition was confirmed for the confidence spinal cmt sys, 11 c (p/n: 283910000, lot #: 272685).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The possible cause could be the cement that may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.Based on the investigation findings, it has been determined that 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.Cement retest results were checked and no concerns were observed with the testing results.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONFIDENCE SPINAL CMT SYS, 11C
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10652334
MDR Text Key210627172
Report Number1526439-2020-01915
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public(01)10705034209623
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
Report Date 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283910000
Device Catalogue Number283910000
Device Lot Number272685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2021
Date Manufacturer Received04/12/2021
Patient Sequence Number1
-
-