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U.S. Department of Health and Human Services

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

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TORNIER S.A.S. CEMENT RESTRICTOR DIAM.24MM SURGICAL MESH Back to Search Results
Model Number EBO101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/24/2021
Event Type  Injury  
Manufacturer Narrative
Device will not be returned. If additional information becomes available, it will be provided on a supplemental report. Device discarded.
 
Event Description
It was reported that the patient had to undergo a revision surgery due to a free floating screw from the ulnar cap. Following this surgery the patient had to undergo another revision due to staphylococcus epidermidis. The initial plan was to swap the spool and cap, however the infection loosened the humeral and ulnar components. Components were removed and an antibiotic cement spacer was placed insitu. The patient will be need a subsequent operation after infection clears to have new components implanted.
 
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Brand NameCEMENT RESTRICTOR DIAM.24MM
Type of DeviceSURGICAL MESH
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
nathe hendricks
11576 memphis arlington rd
arlington, TN 38002
9018679971
MDR Report Key13057008
MDR Text Key287919831
Report Number3000931034-2021-00359
Device Sequence Number1
Product Code FTM
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 Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEBO101
Device Catalogue NumberEBO101
Device Lot Number1400AV068
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2019
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: 12/21/2021 Patient Sequence Number: 1
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