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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORNIER S.A.S. CEMENT RESTRICTOR DIAM.24MM MESH, SURGICAL

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TORNIER S.A.S. CEMENT RESTRICTOR DIAM.24MM MESH, SURGICAL Back to Search Results
Model Number EBO101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/21/2022
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. When additional information becomes available, it will be provided on a supplemental report. Device disposition unknown.
 
Event Description
It was reported that the patient underwent a revision surgery due to an infection 12 months post-op. The metal devices were removed and a competitor's cement spacer was inserted.
 
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Brand NameCEMENT RESTRICTOR DIAM.24MM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR 38330
Manufacturer (Section G)
TORNIER S.A.S.
161 rue lavoisier
montbonnot saint-martin 38330
FR 38330
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key15044272
MDR Text Key296082503
Report Number3000931034-2022-00258
Device Sequence Number1
Product Code FTM
UDI-Device Identifier03700386922053
UDI-Public03700386922053
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K973453
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberEBO101
Device Catalogue NumberEBO101
Device Lot Number0923AW
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2022 Patient Sequence Number: 1
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