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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNK - CAGE/SPACER: CONDUIT EIT - TLIF; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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MEDOS INTERNATIONAL SàRL CH UNK - CAGE/SPACER: CONDUIT EIT - TLIF; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Type  Injury  
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.A1 patient identifier: (b)(6).D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown cage/spacer: conduit eit - tlif /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 synthes reports an event in switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango soa report - tlif.The following complications have been identified: instability.Complication time/intervention.Repeat surgery.This report involves one unk - cage/spacer: conduit eit - tlif this is report 1 of 2 for (b)(4).
 
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Brand Name
UNK - CAGE/SPACER: CONDUIT EIT - TLIF
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key18463034
MDR Text Key332262532
Report Number1526439-2024-00292
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/12/2023
Initial Date FDA Received01/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - CONSTRUCTS: EXPEDIUM.
Patient Outcome(s) Required Intervention;
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