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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Depuy Spine Inc CONDUIT; Intervertebral fusion device with bone graft, lumbar

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Depuy Spine Inc CONDUIT; Intervertebral fusion device with bone graft, lumbar Back to Search Results
Catalog Number TFT30102T
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/04/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the inner shaft got tilted while hammering the cage.There was no patient harm and no surgical delay reported.
 
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
CONDUIT
Common Device Name
Intervertebral fusion device with bone graft, lumbar
Manufacturer (Section D)
Depuy Spine Inc
325 paramount drive
raynham MA 02767
Manufacturer Contact
elba bello
325 paramount drive
raynham, MA 02767
+1(908)386-3534
MDR Report Key50871537
Report Number1526439-2026-01480
Device Sequence Number10716107
Product Code MAX
UDI-Device Identifier10705034557472
Combination Product (Y/N)N
Initial Reporter CountryPO
PMA/510(K) Number
K210728
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Health Professional,Company Representative
Initial 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
Operator of Device Health Professional
Device Catalogue NumberTFT30102T
Device Lot NumberNN400989
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer 09/03/2026
Initial Report FDA Received Date09/23/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured10/22/2025
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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