• 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 KIT SPINAL CEMENT SYSTEM 7CC; ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT

  • 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 KIT SPINAL CEMENT SYSTEM 7CC; ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT Back to Search Results
Catalog Number 283907000
Device Problems Break (1069); Device Difficult to Maintain (3134)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Procode is unknown.Udi: unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.510k: unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a product specialist reported about problems with the cement's confidence.When cement has been filled up and it mixed, the handle froze in one position.The mechanism broke after 10 turns.This complaint involves one (1) device.This report is 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.H3, h6: 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
Product complaint # (b)(4).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.The pump is mostly used, as is the contents of the cement reservoir.However, the cement mixer was returned having its parts seized together due to the cement volume inside.The mixer carries some extra cement weight outside of its own, but it is unknown how much cement is inside.The cement appears to have solidified while still in the mixer.The remaining parts appear to have been used after the original mixer seized.A review of the cement¿s manufacturing records found no issues.There is a possibility the cement 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.A review of the device history record for the kit was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A follow-up dhr review was performed on the high viscosity spinal cement that is part of this kit (product code: 1839-01-001, lot number: 9009078).No discrepancies were observed during the manufacturing process.The root cause of the cement setting prematurely cannot be determined from the sample and the information provided.A potential root cause may be environment factors related to the storage of the cement.No corrective and preventive action (capa) is necessary at this time as no issues could be identified in the manufacturing or release of these products.Therefore, this complaint will be closed with no further action required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONFIDENCE KIT SPINAL CEMENT SYSTEM 7CC
Type of Device
ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9406411
MDR Text Key185294676
Report Number1526439-2019-52552
Device Sequence Number1
Product Code NDN
Combination Product (y/n)N
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 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number283907000
Device Lot Number235030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 11/11/2019
Initial Date FDA Received12/03/2019
Supplement Dates Manufacturer Received01/30/2020
02/04/2020
Supplement Dates FDA Received01/30/2020
02/05/2020
Patient Sequence Number1
-
-