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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
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MEDOS INTERNATIONAL SàRL CH UNKNOWN CAGE/SPACER; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR Back to Search Results
Device Problem Inaccurate Information (4051)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
510k: this report is for an unknown concorde cage/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a company representative.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 that on (b)(6) 2019, the x-ray visualization in the concorde surgical technique appeared to be wrong.It doesn't correspond with the graphics of the cage.There was no reported patient consequence.This report is for an unknown concorde cage.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: h6: customer quality investigation: the following investigation is based on the image(s) provided in the attachment(s) ¿concorde surgical technique guide¿.The image was reviewed, and the complaint condition could not be confirmed, because the x-ray images in the surgical guide corresponds to the concorde ti implants.No definitive root cause could be determined.However few observations from r&d evaluation on provided images per attachment indicates that the implant position is at an angle relative to the x-ray view due to which the two elongated slots are not visible resulting the concern with the surgical technique.During the investigation no surgical guide issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: an updated product investigation was completed: the technique guide was reviewed.The image was reviewed, and the complaint condition could not be confirmed as the x-ray image in the surgical technique guide was confirmed to be for the concorde ti implants.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.
 
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Brand Name
UNKNOWN CAGE/SPACER
Type of Device
INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9540474
MDR Text Key196806139
Report Number1526439-2020-00078
Device Sequence Number1
Product Code MAX
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 12/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received03/05/2020
Patient Sequence Number1
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