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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH T-HANDLE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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EIT EMERGING IMPLANT TECHNOLOGIES GMBH T-HANDLE INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Model Number PET30101
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
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: patient identifier: (b)(6).Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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
It was reported that on december 7, 2022, during implantation of a conduit straight t/pluf cage, the inner driver of the implant holder was found to be disconnected from its handle.This locked the implant to the driver, and prevented the implant from being detached after implantation.The surgeon had to explant and waste the cage.Another cage of the same size was opened, and a different implant inserter was used to complete the surgery.There was a surgical delay of 2 minutes.The implant and implant holder were removed, and a new implant was opened and inserted.The procedure was successfully completed and there was no patient consequence.No further information is available.This report involves one t-handle inserter.This is report 1 of 2 for (b)(4).
 
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Brand Name
T-HANDLE INSERTER
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
eisenbahnstrasse 84
wurmlingen D-785 73
GM  D-78573
Manufacturer Contact
daniel seng
eisenbahnstrasse 84
wurmlingen D-785-73
GM   D-78573
6103142063
MDR Report Key16077430
MDR Text Key307176643
Report Number3013730328-2022-00102
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPET30101
Device Catalogue NumberPET30101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2022
Initial Date FDA Received12/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
INSERTER SH CONNECTION; POST IBF UI H 10MM 8DEG 26/9
Patient Age75 YR
Patient SexFemale
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