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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; CEMENT, BONE, VERTEBROPLASTY

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MEDOS INTERNATIONAL SàRL CH CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY Back to Search Results
Model Number 283910000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2020
Event Type  malfunction  
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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, some of the cement leaked from the yellow stopper while being injected into the cannula.This report is for a confidence spinal cmt sys, 11c.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 t h6: a device history record (dhr) review was conducted: a manufacturing record evaluation was performed for the finished device.Product code: 283910000.Lot number: 258833.It was electronically reviewed and no non conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 24.10.2019.Qty: (b)(4).Cement number: product code : 183901001/batch number : 258833.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 CMT SYS, 11C
Type of Device
CEMENT, BONE, VERTEBROPLASTY
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ  
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key14695349
MDR Text Key294271484
Report Number1526439-2022-00845
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209623
UDI-Public(01)10705034209623
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
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 Model Number283910000
Device Catalogue Number283910000
Device Lot Number258833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/16/2022
Initial Date FDA Received06/15/2022
Supplement Dates Manufacturer Received06/17/2022
Supplement Dates FDA Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2019
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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