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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER 10MM X 28MM 9MM HEIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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SYNTHES GMBH T-PAL SPACER 10MM X 28MM 9MM HEIGHT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Catalog Number 08.812.009S
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2024
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j employee.H3, h6: 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 synthes reports an event in portugal as follows: it was reported that on (b)(6) 2024, the tpal cage broke during the insertion, with little hammering forces.There was a surgical delay of five (5) minutes.Any fragments that were generated were easily removed.The procedure was completed successfully.There were no patient consequences.This report involves one (1) t-pal spacer 10mm x 28mm 9mm height.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.H3, h4, h6 investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history review (dhr): part number: 08.812.009s.Lot number: 402p623.Manufacturing site: hägendorf.Release to warehouse date: 09.Dec.2021.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Corrected data: g1: manufacture site updated.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
T-PAL SPACER 10MM X 28MM 9MM HEIGHT
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
WERK HAEGENDORF
im bifang 6
haegendorf CO 4614
SZ   4614
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18838738
MDR Text Key337019151
Report Number8030965-2024-03239
Device Sequence Number1
Product Code MAX
UDI-Device Identifier07611819405653
UDI-Public(01)07611819405653
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K100089
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,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 Catalogue Number08.812.009S
Device Lot Number402P623
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer Received05/14/2024
Supplement Dates FDA Received05/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/09/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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