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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LDR MEDICAL AVENUE T ANCHORING PLATE, UNKNOWN SIZE; AVENUE T TLIF CAGE
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LDR MEDICAL AVENUE T ANCHORING PLATE, UNKNOWN SIZE; AVENUE T TLIF CAGE Back to Search Results
Catalog Number AT000XT
Device Problem Migration (4003)
Patient Problems Incontinence (1928); Paresis (1998); Stenosis (2263); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3004788213-2020-00178.
 
Event Description
It was reported that a revision was performed to address neurological issues the patient was experiencing because it looked like an avenue t construct migrated post-operatively.It was not possible for the surgeon to remove the construct because he did not have the correct instruments for removal; he cleaned the discal tissue surrounding the cage.No further information has been provided at this time.This is report two of two for this event.
 
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
 
Event Description
It was reported that a revision was performed to address neurological issues the patient was experiencing because it looked like an avenue t construct migrated post-operatively.It was not possible for the surgeon to remove the construct because he did not have the correct instruments for removal; he cleaned the discal tissue surrounding the cage.No further information has been provided at this time.This is report two of two for this event.
 
Event Description
It was reported that a revision was performed to address neurological issues the patient was experiencing because it looked like an avenue t construct migrated post-operatively.It was not possible for the surgeon to remove the construct because he did not have the correct instruments for removal; he cleaned the discal tissue surrounding the cage.No further information has been provided at this time.This is report two of two for this event.
 
Manufacturer Narrative
Additional information in h6: method, results, and conclusions.The devices remain implanted after the revision surgery.A ct image was provided, and appears to show some evidence of posterior placement of an implant that could have potentially been the result of migration, though this can't be confirmed without intraoperative and post-operative images to compare.The complaint is unrefuted.Root cause was unable to be determined with the available information.It's possible improper installation and/or fixation during the initial surgery or improper post-op patient movement contributed to the event.The lot number was not provided, so the dhr review was unable to be performed.This device is used for treatment.If additional information is received that changes information in this report, a follow-up report will be submitted.
 
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Brand Name
AVENUE T ANCHORING PLATE, UNKNOWN SIZE
Type of Device
AVENUE T TLIF CAGE
Manufacturer (Section D)
LDR MEDICAL
quartier europe de l¿ouest
5, rue de berlin
sainte-savine, na 10300
FR  10300
MDR Report Key10788556
MDR Text Key214744696
Report Number3004788213-2020-00201
Device Sequence Number1
Product Code OVD
Combination Product (y/n)N
PMA/PMN Number
K161173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAT000XT
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age46 YR
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