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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 10MM X 38CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN 10MM X 38CM LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71649638
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 10/23/2020
Event Type  Injury  
Event Description
It was reported that meta tan left 10mm x 38 had to be exchanged due to non-union. No patient information was initially provided.
 
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Brand NameMETA-TAN 10MM X 38CM LEFT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
1450 brooks rd.
memphis, TN 38116
5123913905
MDR Report Key10850463
MDR Text Key216559187
Report Number1020279-2020-06533
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K092748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number71649638
Device Catalogue Number71649638
Device Lot Number18AM20498
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2018
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: 11/17/2020 Patient Sequence Number: 1
Treatment
TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19AM11379; TRIGENLOWPROFILESCREW5.0MMX40MM/71645040/19DM01200; TRIGENLOWPROFILESCREW5.0MMX65MM/71645065/18KM04120
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